{
  "code": "GCJ",
  "deviceName": "Laparoscope, General & Plastic Surgery",
  "deviceClass": "II",
  "regulationNumber": "876.1500",
  "panel": "Gastroenterology, Urology",
  "definition": "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 1426,
    "last12Months": 30
  },
  "adverseEvents": {
    "total": 18007,
    "last12Months": 4416
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 1426
  },
  "recalls": {
    "total": 274,
    "recent": [
      {
        "resNumber": "Z-2761-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.",
        "initiated": "2026-07-07"
      },
      {
        "resNumber": "Z-1010-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Applied Medical Resources Corp",
        "firmAsPublished": "Applied Medical Resources Corp",
        "reason": "There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.",
        "initiated": "2025-12-11"
      },
      {
        "resNumber": "Z-0309-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aesculap, Inc.",
        "firmAsPublished": "Aesculap Inc",
        "reason": "It was determined there is the potential of silicone fragments detaching from the yellow sealing component.",
        "initiated": "2025-09-24"
      },
      {
        "resNumber": "Z-0310-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aesculap, Inc.",
        "firmAsPublished": "Aesculap Inc",
        "reason": "It was determined there is the potential of silicone fragments detaching from the yellow sealing component.",
        "initiated": "2025-09-24"
      },
      {
        "resNumber": "Z-0311-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aesculap, Inc.",
        "firmAsPublished": "Aesculap Inc",
        "reason": "It was determined there is the potential of silicone fragments detaching from the yellow sealing component.",
        "initiated": "2025-09-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253541",
      "deviceName": "EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)",
      "applicant": "Medical Impact",
      "company": "Medical Impact",
      "decisionDate": "2026-07-24",
      "dateReceived": "2025-11-14"
    },
    {
      "kNumber": "K261614",
      "deviceName": "LED LCD Monitor (OEV-271H)",
      "applicant": "Lg Electronics.Inc",
      "company": "LG ELECTRONICS INC.",
      "decisionDate": "2026-07-17",
      "dateReceived": "2026-05-15"
    },
    {
      "kNumber": "K261249",
      "deviceName": "Universal Seal (5-12 mm)",
      "applicant": "Intuitive Surgical, Inc.",
      "company": "Intuitive Surgical, Inc.",
      "decisionDate": "2026-07-14",
      "dateReceived": "2026-04-16"
    },
    {
      "kNumber": "K260710",
      "deviceName": "FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)",
      "applicant": "FloShield, Inc.",
      "company": "FloShield, Inc.",
      "decisionDate": "2026-06-11",
      "dateReceived": "2026-03-04"
    },
    {
      "kNumber": "K260414",
      "deviceName": "“Tech-Image” Video Endoscope System",
      "applicant": "Tech-Image CO., LTD.",
      "company": "Tech-Image CO., LTD.",
      "decisionDate": "2026-06-10",
      "dateReceived": "2026-02-09"
    },
    {
      "kNumber": "K253994",
      "deviceName": "TroKit Laparoscope Lens Wiper",
      "applicant": "TroCare, LLC",
      "company": "TroCare, LLC",
      "decisionDate": "2026-06-04",
      "dateReceived": "2025-12-12"
    },
    {
      "kNumber": "K252532",
      "deviceName": "Inno-Port Disposable Bladed Trocar",
      "applicant": "Taiwan Surgical Corporation",
      "company": "Taiwan Surgical Corporation",
      "decisionDate": "2026-06-02",
      "dateReceived": "2025-08-12"
    },
    {
      "kNumber": "K260318",
      "deviceName": "4K NIR/ICG Imaging System",
      "applicant": "Zhejiang Healnoc Technology Co., Ltd.",
      "company": "Zhejiang Healnoc Technology Co., Ltd.",
      "decisionDate": "2026-05-26",
      "dateReceived": "2026-01-30"
    },
    {
      "kNumber": "K260183",
      "deviceName": "MediBot Needle Driver Uno",
      "applicant": "Parallel Robotics, LLC",
      "company": "Parallel Robotics, LLC",
      "decisionDate": "2026-05-24",
      "dateReceived": "2026-01-21"
    },
    {
      "kNumber": "K252985",
      "deviceName": "Laport",
      "applicant": "Sejong Medical Co., Ltd.",
      "company": "Sejong Medical Co., Ltd.",
      "decisionDate": "2026-05-19",
      "dateReceived": "2025-09-18"
    }
  ],
  "topApplicants": [
    {
      "name": "KARL STORZ Endoscopy-America, Inc.",
      "count": 47
    },
    {
      "name": "Origin Medsystems, Inc.",
      "count": 34
    },
    {
      "name": "Phx Technologies Corp.",
      "count": 33
    },
    {
      "name": "United States Surgical, A Division of Tyco Healthc",
      "count": 30
    },
    {
      "name": "Ethicon Endo-Surgery, Inc.",
      "count": 28
    }
  ],
  "topCompanies": [
    {
      "name": "Karl Storz Endoscopy America Inc",
      "count": 51,
      "spellings": 3
    },
    {
      "name": "Origin Medsystems, Inc.",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Phx Technologies Corp.",
      "count": 33,
      "spellings": 1
    },
    {
      "name": "Ethicon Endo Surgery,  LLC",
      "count": 31,
      "spellings": 2
    },
    {
      "name": "United States Surgical, A Division of Tyco Healthc",
      "count": 30,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Medical Impact",
      "since": "2026-07-24",
      "kNumber": "K253541"
    },
    {
      "name": "FloShield, Inc.",
      "since": "2026-06-11",
      "kNumber": "K260710"
    },
    {
      "name": "Tech-Image CO., LTD.",
      "since": "2026-06-10",
      "kNumber": "K260414"
    },
    {
      "name": "Zhejiang Healnoc Technology Co., Ltd.",
      "since": "2026-05-26",
      "kNumber": "K260318"
    },
    {
      "name": "Parallel Robotics, LLC",
      "since": "2026-05-24",
      "kNumber": "K260183"
    },
    {
      "name": "Kms Medical Technology Co., Ltd.",
      "since": "2026-04-30",
      "kNumber": "K252858"
    },
    {
      "name": "Scopix , Ltd.",
      "since": "2026-04-08",
      "kNumber": "K260089"
    },
    {
      "name": "Suzhou Shenyun Medical Equipment Co., Ltd.",
      "since": "2026-04-08",
      "kNumber": "K260197"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 353,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 370,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 398,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 423,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 544,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 576,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 430,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 511,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 467,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 518,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 613,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 594,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 581,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 537,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 519,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 488,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 492,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 466,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 508,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 363,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 368,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 331,
        "expectedLow": 203.8134181940439,
        "expectedHigh": 587.1306090669021,
        "isSufficient": true
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        "month": "2025-02-01",
        "observed": 335,
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        "isSufficient": true
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        "month": "2025-03-01",
        "observed": 414,
        "expectedLow": 181.22491560676747,
        "expectedHigh": 558.7864071369601,
        "isSufficient": true
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        "month": "2025-04-01",
        "observed": 511,
        "expectedLow": 227.46476313708183,
        "expectedHigh": 564.4023830552586,
        "isSufficient": true
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        "month": "2025-05-01",
        "observed": 489,
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        "isSufficient": true
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        "month": "2025-06-01",
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        "expectedLow": 302.1970040707722,
        "expectedHigh": 587.374335098685,
        "isSufficient": true
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        "month": "2025-07-01",
        "observed": 566,
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        "expectedHigh": 927.6859741591636,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 508,
        "expectedLow": 348.9012761184407,
        "expectedHigh": 670.3826907039229,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 473,
        "expectedLow": 366.5681846891831,
        "expectedHigh": 704.8690850579607,
        "isSufficient": true
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      {
        "month": "2025-10-01",
        "observed": 543,
        "expectedLow": 344.6819096146279,
        "expectedHigh": 682.5466971800508,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 481,
        "expectedLow": 316.3357166336407,
        "expectedHigh": 622.2076574494743,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 603,
        "expectedLow": 364.8903740173716,
        "expectedHigh": 682.72888393132,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 560,
        "expectedLow": 460.1057475238375,
        "expectedHigh": 803.5495231929369,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 599,
        "expectedLow": 391.08573135725294,
        "expectedHigh": 643.1732687570657,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 770,
        "expectedLow": 457.8678426805344,
        "expectedHigh": 731.2928031838122,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "GCJ (Laparoscope, General & Plastic Surgery) has seven findings, most consequential first. K261614 cites a recalled device one generation upstream — K220069, recall Z-2761-2026 (Class II, Open, Classified). K253541 cites a recalled device 2 generations upstream — K220069, recall Z-2761-2026 (Class II, Open, Classified). 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2761-2026, Z-1010-2026, Z-0309-2026, Z-0310-2026, Z-0311-2026). Adverse events reported in 2026-03 ran high — 770 reports against an expected 458 to 731 (GCJ:MAUDE:2026-03). 16 first-time filers in the last 12 months, including Medical Impact and FloShield, Inc (K253541, K260710, K260414, K260318, K260183). Clearances are running 32% slower — a median 116 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days) (GCJ:review_time:12m). The code is crowded, scoring 100 of 100 — 511 companies hold a clearance here and 30 arrived in the last 12 months (GCJ:crowding).",
    "severity": 90,
    "factors": [
      {
        "kind": "predicate_risk",
        "detail": "K261614 cites a recalled device one generation upstream — K220069, recall Z-2761-2026 (Class II, Open, Classified)",
        "recordIds": [
          "K261614",
          "K220069",
          "Z-2761-2026"
        ],
        "severity": 90
      },
      {
        "kind": "predicate_risk",
        "detail": "K253541 cites a recalled device 2 generations upstream — K220069, recall Z-2761-2026 (Class II, Open, Classified)",
        "recordIds": [
          "K253541",
          "K220069",
          "Z-2761-2026"
        ],
        "severity": 88
      },
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2761-2026",
          "Z-1010-2026",
          "Z-0309-2026",
          "Z-0310-2026",
          "Z-0311-2026"
        ],
        "severity": 75
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 770 reports against an expected 458 to 731",
        "recordIds": [
          "GCJ:MAUDE:2026-03"
        ],
        "severity": 63
      },
      {
        "kind": "new_entrant",
        "detail": "16 first-time filers in the last 12 months, including Medical Impact and FloShield, Inc.",
        "recordIds": [
          "K253541",
          "K260710",
          "K260414",
          "K260318",
          "K260183"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 32% slower — a median 116 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "GCJ:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 511 companies hold a clearance here and 30 arrived in the last 12 months",
        "recordIds": [
          "GCJ:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [
      {
        "child": "K253541",
        "parent": "K261614",
        "source": "manual"
      },
      {
        "child": "K261614",
        "parent": "K220069",
        "source": "manual"
      }
    ],
    "note": null
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AGCJ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGCJ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGCJ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGCJ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGCJ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGCJ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGCJ"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.700Z"
}