{
  "companyId": "55589",
  "slug": "wilson-cook-medical-inc-55589",
  "name": "Wilson-Cook Medical Inc.",
  "clearances": {
    "total": 126,
    "last12Months": 2,
    "first": "1985-05-17",
    "latest": "2026-06-02"
  },
  "medianReviewDays": 88,
  "productCodeCount": 41,
  "recalls": {
    "total": 44,
    "openLast12Months": 3,
    "recent": [
      {
        "resNumber": "Z-1812-2026",
        "productCode": "PKL",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-03",
        "reason": "Due to increased in complaints their is the  potential for endoscopic clipping device to malfunction."
      },
      {
        "resNumber": "Z-1362-2026",
        "productCode": "KNS",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-12-18",
        "reason": "Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting."
      },
      {
        "resNumber": "Z-1298-2026",
        "productCode": "KNT",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-12-15",
        "reason": "Nasal feeding tube packaged without the nasal transfer tube component."
      },
      {
        "resNumber": "Z-0582-2025",
        "productCode": "QAU",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-10-31",
        "reason": "Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated."
      },
      {
        "resNumber": "Z-0036-2025",
        "productCode": "QAU",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-08-29",
        "reason": "Specific lots of product have been manufactured with nonconforming raw materials."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "FGE",
      "deviceName": "Stents, Drains And Dilators For The Biliary Ducts",
      "clearances": 20,
      "latest": "2017-10-13",
      "medianReviewDays": 84
    },
    {
      "code": "KNS",
      "deviceName": "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)",
      "clearances": 12,
      "latest": "2025-09-29",
      "medianReviewDays": 65
    },
    {
      "code": "KNT",
      "deviceName": "Tubes, Gastrointestinal (And Accessories)",
      "clearances": 12,
      "latest": "2020-06-17",
      "medianReviewDays": 119
    },
    {
      "code": "GCA",
      "deviceName": "Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection",
      "clearances": 7,
      "latest": "2020-02-27",
      "medianReviewDays": 28
    },
    {
      "code": "FCG",
      "deviceName": "Biopsy Needle",
      "clearances": 5,
      "latest": "2017-08-04",
      "medianReviewDays": 122
    },
    {
      "code": "FDX",
      "deviceName": "Endoscopic Cytology Brush",
      "clearances": 5,
      "latest": "2019-11-14",
      "medianReviewDays": 159
    },
    {
      "code": "OCY",
      "deviceName": "Endoscopic Guidewire, Gastroenterology-Urology",
      "clearances": 5,
      "latest": "2014-11-05",
      "medianReviewDays": 29
    },
    {
      "code": "FBK",
      "deviceName": "Endoscopic Injection Needle, Gastroenterology-Urology",
      "clearances": 4,
      "latest": "2011-07-19",
      "medianReviewDays": 63
    },
    {
      "code": "EOQ",
      "deviceName": "Bronchoscope (Flexible Or Rigid)",
      "clearances": 3,
      "latest": "2018-02-21",
      "medianReviewDays": 110
    },
    {
      "code": "ESW",
      "deviceName": "Prosthesis, Esophageal",
      "clearances": 3,
      "latest": "2002-07-19",
      "medianReviewDays": 421
    },
    {
      "code": "GAA",
      "deviceName": "Needle, Aspiration And Injection, Disposable",
      "clearances": 3,
      "latest": "1990-04-16",
      "medianReviewDays": 14
    },
    {
      "code": "KGE",
      "deviceName": "Forceps, Biopsy, Electric",
      "clearances": 3,
      "latest": "2018-03-21",
      "medianReviewDays": 264
    },
    {
      "code": "KNQ",
      "deviceName": "Dilator, Esophageal",
      "clearances": 3,
      "latest": "1994-11-29",
      "medianReviewDays": 297
    },
    {
      "code": "LQR",
      "deviceName": "Dislodger, Stone, Biliary",
      "clearances": 3,
      "latest": "2018-10-30",
      "medianReviewDays": 88
    },
    {
      "code": "PKL",
      "deviceName": "Hemostatic Metal Clip For The Gi Tract",
      "clearances": 3,
      "latest": "2021-08-25",
      "medianReviewDays": 46
    },
    {
      "code": "FCK",
      "deviceName": "Instrument, Biopsy, Suction",
      "clearances": 2,
      "latest": "2017-04-06",
      "medianReviewDays": 97
    },
    {
      "code": "FDI",
      "deviceName": "Snare, Flexible",
      "clearances": 2,
      "latest": "2019-07-18",
      "medianReviewDays": 90
    },
    {
      "code": "FFX",
      "deviceName": "System, Gastrointestinal Motility (Electrical)",
      "clearances": 2,
      "latest": "2016-06-20",
      "medianReviewDays": 145
    },
    {
      "code": "KLA",
      "deviceName": "Monitor, Esophageal Motility, Anorectal Motility, And Tube",
      "clearances": 2,
      "latest": "1991-01-25",
      "medianReviewDays": 180
    },
    {
      "code": "KNW",
      "deviceName": "Instrument, Biopsy",
      "clearances": 2,
      "latest": "1987-12-29",
      "medianReviewDays": 48
    },
    {
      "code": "LQC",
      "deviceName": "Lithotriptor, Biliary Mechanical",
      "clearances": 2,
      "latest": "2001-05-04",
      "medianReviewDays": 17
    },
    {
      "code": "ODC",
      "deviceName": "Endoscope Channel Accessory",
      "clearances": 2,
      "latest": "2022-04-26",
      "medianReviewDays": 179
    },
    {
      "code": "ODD",
      "deviceName": "Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",
      "clearances": 2,
      "latest": "2018-03-20",
      "medianReviewDays": 90
    },
    {
      "code": "QAU",
      "deviceName": "Hemostatic Device For Endoscopic Gastrointestinal Use",
      "clearances": 2,
      "latest": "2026-06-02",
      "medianReviewDays": 58
    },
    {
      "code": "BSP",
      "deviceName": "Needle, Conduction, Anesthetic (W/Wo Introducer)",
      "clearances": 1,
      "latest": "2003-05-27",
      "medianReviewDays": 90
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "41",
  "recentClearances": [
    {
      "kNumber": "K253302",
      "deviceName": "Hemospray Endoscopic Hemostat (HEMO-[X])",
      "productCode": "QAU",
      "decisionDate": "2026-06-02",
      "reviewDays": 246
    },
    {
      "kNumber": "K251104",
      "deviceName": "SureTome™ SW Sphincterotome with DomeTip",
      "productCode": "KNS",
      "decisionDate": "2025-09-29",
      "reviewDays": 171
    },
    {
      "kNumber": "K243568",
      "deviceName": "Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord",
      "productCode": "KNS",
      "decisionDate": "2025-01-17",
      "reviewDays": 60
    },
    {
      "kNumber": "K213483",
      "deviceName": "SnapLoc Wire Lock",
      "productCode": "ODC",
      "decisionDate": "2022-04-26",
      "reviewDays": 179
    },
    {
      "kNumber": "K213356",
      "deviceName": "Entuit PEG, Entuit PEGJ",
      "productCode": "PIF",
      "decisionDate": "2022-01-20",
      "reviewDays": 100
    },
    {
      "kNumber": "K212323",
      "deviceName": "Instinct Plus Endoscopic Clipping Device",
      "productCode": "PKL",
      "decisionDate": "2021-08-25",
      "reviewDays": 30
    },
    {
      "kNumber": "K201322",
      "deviceName": "Entuit Nasal Jejunal Feeding Tube",
      "productCode": "KNT",
      "decisionDate": "2020-06-17",
      "reviewDays": 30
    },
    {
      "kNumber": "K200972",
      "deviceName": "Hemospray Endoscopic Hemostat",
      "productCode": "QAU",
      "decisionDate": "2020-06-10",
      "reviewDays": 58
    },
    {
      "kNumber": "K200247",
      "deviceName": "Fusion Quattro Extraction Balloon",
      "productCode": "GCA",
      "decisionDate": "2020-02-27",
      "reviewDays": 27
    },
    {
      "kNumber": "K192339",
      "deviceName": "TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord",
      "productCode": "KNS",
      "decisionDate": "2020-01-30",
      "reviewDays": 155
    }
  ],
  "nameVariants": {
    "total": "7",
    "shown": [
      {
        "name": "Wilson Cook Medical",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Wilson-Cook Medical",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Wilson-Cook Medical Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Wilson-Cook Medical Inc.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Wilson-Cook Medical Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Wilson-Cook Medical Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Wilson-Cook Medical, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Wilson-Cook%20Medical%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Wilson-Cook%20Medical%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.037Z"
}