{
  "code": "HET",
  "deviceName": "Laparoscope, Gynecologic (And Accessories)",
  "deviceClass": "II",
  "regulationNumber": "884.1720",
  "panel": "Obstetrics/Gynecology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 338,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 9778,
    "last12Months": 3269
  },
  "reviewDays": {
    "median": 150,
    "sampleSize": 338
  },
  "recalls": {
    "total": 19,
    "recent": [
      {
        "resNumber": "Z-1473-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Karl Storz Endoscopy",
        "firmAsPublished": "Karl Storz Endoscopy",
        "reason": "Inadequate reprocessing validation evidence",
        "initiated": "2024-02-27"
      },
      {
        "resNumber": "Z-0644-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in\nthe Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes",
        "initiated": "2023-11-20"
      },
      {
        "resNumber": "Z-0645-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in\nthe Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes",
        "initiated": "2023-11-20"
      },
      {
        "resNumber": "Z-0697-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.",
        "initiated": "2023-11-06"
      },
      {
        "resNumber": "Z-0573-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Karl Storz Endoscopy",
        "firmAsPublished": "Karl Storz Endoscopy",
        "reason": "The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.",
        "initiated": "2023-10-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K250939",
      "deviceName": "SIRIUS Endoscope System (PR-SI-1230)",
      "applicant": "Precision Robotics (Hong Kong) Limited",
      "company": "Precision Robotics (Hong Kong) Limited",
      "decisionDate": "2025-08-29",
      "dateReceived": "2025-03-28"
    },
    {
      "kNumber": "K243821",
      "deviceName": "i-Cut",
      "applicant": "A.M.I. Agency For Medical Innovations GmbH",
      "company": "A.M.I. Agency For Medical Innovations GmbH",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-12-12"
    },
    {
      "kNumber": "K221642",
      "deviceName": "SIRIUS Endoscope System",
      "applicant": "Precision Robotics (Hong Kong) Limited",
      "company": "Precision Robotics (Hong Kong) Limited",
      "decisionDate": "2022-12-12",
      "dateReceived": "2022-06-06"
    },
    {
      "kNumber": "K210116",
      "deviceName": "Video Endoscopy System, 3D Video Endoscopy System",
      "applicant": "Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.",
      "company": "Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.",
      "decisionDate": "2021-10-13",
      "dateReceived": "2021-01-19"
    },
    {
      "kNumber": "K201832",
      "deviceName": "Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5",
      "applicant": "Olympus Medical Systems Corp.",
      "company": "Olympus Medical Systems Corporation",
      "decisionDate": "2021-09-17",
      "dateReceived": "2020-07-02"
    },
    {
      "kNumber": "K210104",
      "deviceName": "SurroundScope System",
      "applicant": "270surgical , Ltd.",
      "company": "270surgical , Ltd.",
      "decisionDate": "2021-07-08",
      "dateReceived": "2021-01-14"
    },
    {
      "kNumber": "K201617",
      "deviceName": "TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))",
      "applicant": "Schoelly Fiberoptic GmbH",
      "company": "SCHOELLY FIBEROPTIC, GMBH",
      "decisionDate": "2021-03-12",
      "dateReceived": "2020-06-15"
    },
    {
      "kNumber": "K200216",
      "deviceName": "4K UHD Camera System",
      "applicant": "Scivita Medical Technology Co., Ltd.",
      "company": "Scivita Medical Technology Co., Ltd.",
      "decisionDate": "2020-08-21",
      "dateReceived": "2020-01-28"
    },
    {
      "kNumber": "K200638",
      "deviceName": "LAP-iX Suction Irrigation",
      "applicant": "Sejong Medical Co., Ltd.",
      "company": "Sejong Medical Co., Ltd.",
      "decisionDate": "2020-04-03",
      "dateReceived": "2020-03-10"
    },
    {
      "kNumber": "K190190",
      "deviceName": "WV1 Endoscope",
      "applicant": "270surgical , Ltd.",
      "company": "270surgical , Ltd.",
      "decisionDate": "2019-11-01",
      "dateReceived": "2019-02-01"
    }
  ],
  "topApplicants": [
    {
      "name": "KARL STORZ Endoscopy-America, Inc.",
      "count": 29
    },
    {
      "name": "Dixon Medical, Inc.",
      "count": 12
    },
    {
      "name": "ETHICON, Inc.",
      "count": 11
    },
    {
      "name": "Marlo Surgical Technology",
      "count": 10
    },
    {
      "name": "Baxter Healthcare Corp",
      "count": 9
    }
  ],
  "topCompanies": [
    {
      "name": "Karl Storz Endoscopy America Inc",
      "count": 29,
      "spellings": 1
    },
    {
      "name": "Dixon Medical, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "ETHICON, INC.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Marlo Surgical Technology",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Baxter Healthcare Corporation",
      "count": 9,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 83,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 69,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 66,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 66,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 62,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 71,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 53,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 206,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 504,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 423,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 451,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 309,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 382,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 357,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 198,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 469,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 446,
        "expectedLow": 14.201901045518362,
        "expectedHigh": 624.6620247684024,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 370,
        "expectedLow": 57.24710832722917,
        "expectedHigh": 564.9358026146888,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 298,
        "expectedLow": 123.0304896160575,
        "expectedHigh": 613.3103870301569,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 361,
        "expectedLow": 166.0261637062948,
        "expectedHigh": 555.2972015806774,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 291,
        "expectedLow": 180.20148285890465,
        "expectedHigh": 503.3562258548108,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 278,
        "expectedLow": 181.8293405369439,
        "expectedHigh": 494.49879840131973,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 295,
        "expectedLow": 267.92591777840454,
        "expectedHigh": 736.6187808336892,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 332,
        "expectedLow": 133.99009778906492,
        "expectedHigh": 527.2982388247862,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 297,
        "expectedLow": 144.04499787423782,
        "expectedHigh": 555.425124093405,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 369,
        "expectedLow": 121.05711250823902,
        "expectedHigh": 540.8248395744621,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 401,
        "expectedLow": 117.42593406141806,
        "expectedHigh": 495.8700171956342,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 652,
        "expectedLow": 188.10389486451365,
        "expectedHigh": 562.1977385400388,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 305,
        "expectedLow": 262.88097305383775,
        "expectedHigh": 795.522088384381,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 368,
        "expectedLow": 167.03027692178014,
        "expectedHigh": 613.8070215571411,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 632,
        "expectedLow": 189.5600581794621,
        "expectedHigh": 647.4435475324032,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HET (Laparoscope, Gynecologic (And Accessories)): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AHET"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHET"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHET"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHET"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHET"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHET"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHET"
    }
  ],
  "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": "2026-08-11T13:51:45.707Z"
}