{
  "code": "GEH",
  "deviceName": "Unit, Cryosurgical, Accessories",
  "deviceClass": "II",
  "regulationNumber": "878.4350",
  "panel": "General, Plastic Surgery",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 263,
    "last12Months": 12
  },
  "adverseEvents": {
    "total": 508,
    "last12Months": 161
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 263
  },
  "recalls": {
    "total": 105,
    "recent": [
      {
        "resNumber": "Z-1566-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Erbe USA Inc",
        "firmAsPublished": "Erbe USA Inc",
        "reason": "Probes may rupture/burst during activation",
        "initiated": "2026-02-12"
      },
      {
        "resNumber": "Z-1567-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Erbe USA Inc",
        "firmAsPublished": "Erbe USA Inc",
        "reason": "Probes may rupture/burst during activation",
        "initiated": "2026-02-12"
      },
      {
        "resNumber": "Z-1568-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Erbe USA Inc",
        "firmAsPublished": "Erbe USA Inc",
        "reason": "Probes may rupture/burst during activation",
        "initiated": "2026-02-12"
      },
      {
        "resNumber": "Z-2550-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.",
        "initiated": "2025-08-18"
      },
      {
        "resNumber": "Z-2551-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.",
        "initiated": "2025-08-18"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261068",
      "deviceName": "Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)",
      "applicant": "Serpex Medical",
      "company": "Serpex Medical, Inc.",
      "decisionDate": "2026-06-30",
      "dateReceived": "2026-04-01"
    },
    {
      "kNumber": "K261806",
      "deviceName": "ERBECRYO 2 Cryosurgical Unit and Accessories",
      "applicant": "Erbe Elektromedizin GmbH",
      "company": "Erbe Elektromedizin GmbH",
      "decisionDate": "2026-06-09",
      "dateReceived": "2026-06-01"
    },
    {
      "kNumber": "K253230",
      "deviceName": "ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe",
      "applicant": "Erbe Elektromedizin GmbH",
      "company": "Erbe Elektromedizin GmbH",
      "decisionDate": "2026-04-22",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K252198",
      "deviceName": "Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)",
      "applicant": "Medical Brands Laboratories B.V.",
      "company": "Medical Brands Laboratories B.V.",
      "decisionDate": "2026-04-02",
      "dateReceived": "2025-07-14"
    },
    {
      "kNumber": "K260377",
      "deviceName": "XSense Cryoablation System with CryoProbes",
      "applicant": "IceCure Medical , Ltd.",
      "company": "Icecure Medical Ltd",
      "decisionDate": "2026-02-24",
      "dateReceived": "2026-02-05"
    },
    {
      "kNumber": "K251928",
      "deviceName": "CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)",
      "applicant": "Medinice S.A.",
      "company": "Medinice S.A.",
      "decisionDate": "2026-02-13",
      "dateReceived": "2025-06-23"
    },
    {
      "kNumber": "K251524",
      "deviceName": "Dr. Yglo Skin Tag Remover",
      "applicant": "Theotclab Healthcare B.V.",
      "company": "Theotclab Healthcare B.V.",
      "decisionDate": "2026-01-12",
      "dateReceived": "2025-05-16"
    },
    {
      "kNumber": "K250742",
      "deviceName": "Focused Cryotherapy System",
      "applicant": "Focused Cryo, Inc.",
      "company": "Focused Cryo, Inc.",
      "decisionDate": "2025-12-09",
      "dateReceived": "2025-03-11"
    },
    {
      "kNumber": "K253114",
      "deviceName": "TargetCool™ (RM-DT02W)",
      "applicant": "Recensmedical, Inc.",
      "company": "Recensmedical, Inc.",
      "decisionDate": "2025-10-16",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K253000",
      "deviceName": "CryoFreeze Wart and Skin Tag Remover",
      "applicant": "Cryosurgery, Inc.",
      "company": "Cryosurgery, Inc.",
      "decisionDate": "2025-10-16",
      "dateReceived": "2025-09-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Galil Medical , Ltd.",
      "count": 22
    },
    {
      "name": "CSA Medical, Inc.",
      "count": 14
    },
    {
      "name": "Endocare, Inc.",
      "count": 13
    },
    {
      "name": "Cryomedical Sciences, Inc.",
      "count": 9
    },
    {
      "name": "AtriCure, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Galil Medical, Inc.",
      "count": 29,
      "spellings": 2
    },
    {
      "name": "CSA Medical",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Endocare, Division Of Healthtronics",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Cryomedical Sciences, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "AtriCure, Inc.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Serpex Medical, Inc.",
      "since": "2026-06-30",
      "kNumber": "K261068"
    },
    {
      "name": "Medinice S.A.",
      "since": "2026-02-13",
      "kNumber": "K251928"
    },
    {
      "name": "Focused Cryo, Inc.",
      "since": "2025-12-09",
      "kNumber": "K250742"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 7,
        "expectedLow": 2.9294572109142654,
        "expectedHigh": 21.21551713033377,
        "isSufficient": true
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      {
        "month": "2025-02-01",
        "observed": 9,
        "expectedLow": 1.5103521580678752,
        "expectedHigh": 17.037775812479204,
        "isSufficient": true
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        "month": "2025-03-01",
        "observed": 10,
        "expectedLow": 1.6229627538497604,
        "expectedHigh": 18.902787469386023,
        "isSufficient": true
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        "month": "2025-04-01",
        "observed": 11,
        "expectedLow": 1.4881047246734664,
        "expectedHigh": 19.365936050701187,
        "isSufficient": true
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      {
        "month": "2025-05-01",
        "observed": 20,
        "expectedLow": 2.6829336409451625,
        "expectedHigh": 17.360858482593816,
        "isSufficient": true
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        "month": "2025-06-01",
        "observed": 4,
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        "expectedHigh": 22.94810403286241,
        "isSufficient": true
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        "month": "2025-07-01",
        "observed": 18,
        "expectedLow": 2.966319481868582,
        "expectedHigh": 30.381051373403263,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 25,
        "expectedLow": 2.597002676709359,
        "expectedHigh": 23.325100672608848,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 14,
        "expectedLow": 4.291244582383869,
        "expectedHigh": 30.38993950055331,
        "isSufficient": true
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      {
        "month": "2025-10-01",
        "observed": 10,
        "expectedLow": 3.5175193139922776,
        "expectedHigh": 28.955024982093754,
        "isSufficient": true
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      {
        "month": "2025-11-01",
        "observed": 20,
        "expectedLow": 1.454825488486441,
        "expectedHigh": 24.484918612379214,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 23,
        "expectedLow": 3.397918076910607,
        "expectedHigh": 30.220557780706667,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 28,
        "expectedLow": 5.268161378212276,
        "expectedHigh": 37.45415647927312,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 23,
        "expectedLow": 6.131709255333304,
        "expectedHigh": 33.48707432917081,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 27,
        "expectedLow": 7.552115242118255,
        "expectedHigh": 37.978219489650655,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "GEH (Unit, Cryosurgical, Accessories) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-1566-2026, Z-1567-2026, Z-1568-2026, Z-2550-2025, Z-2551-2025). 3 first-time filers in the last 12 months, including Serpex Medical, Inc. and Medinice S.A (K261068, K251928, K250742). Clearances are running 67% faster — a median 29 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days) (GEH:review_time:12m). The code is crowded, scoring 85 of 100 — 98 companies hold a clearance here and 12 arrived in the last 12 months (GEH:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I, Class II)",
        "recordIds": [
          "Z-1566-2026",
          "Z-1567-2026",
          "Z-1568-2026",
          "Z-2550-2025",
          "Z-2551-2025"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Serpex Medical, Inc. and Medinice S.A.",
        "recordIds": [
          "K261068",
          "K251928",
          "K250742"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 67% faster — a median 29 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "GEH:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 85 of 100 — 98 companies hold a clearance here and 12 arrived in the last 12 months",
        "recordIds": [
          "GEH:crowding"
        ],
        "severity": 20
      }
    ],
    "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%3AGEH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGEH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGEH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGEH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGEH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGEH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGEH"
    }
  ],
  "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": "2026-08-11T13:51:45.702Z"
}