{
  "companyId": "50399",
  "slug": "cook-incorporated-50399",
  "name": "Cook Incorporated",
  "clearances": {
    "total": 364,
    "last12Months": 0,
    "first": "1976-12-06",
    "latest": "2024-03-08"
  },
  "medianReviewDays": 142,
  "productCodeCount": 92,
  "recalls": {
    "total": 649,
    "openLast12Months": 24,
    "recent": [
      {
        "resNumber": "Z-1934-2026",
        "productCode": "DQO",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-04-02",
        "reason": "Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death."
      },
      {
        "resNumber": "Z-1935-2026",
        "productCode": "DQO",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-04-02",
        "reason": "Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death."
      },
      {
        "resNumber": "Z-1936-2026",
        "productCode": "DQO",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-04-02",
        "reason": "Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death."
      },
      {
        "resNumber": "Z-1775-2026",
        "productCode": "DQX",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-05",
        "reason": "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life."
      },
      {
        "resNumber": "Z-1776-2026",
        "productCode": "DQX",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-05",
        "reason": "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life."
      }
    ]
  },
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    "sites": 5,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
      "clearances": 26,
      "latest": "2019-07-22",
      "medianReviewDays": 89
    },
    {
      "code": "DQY",
      "deviceName": "Catheter, Percutaneous",
      "clearances": 22,
      "latest": "2019-12-12",
      "medianReviewDays": 37
    },
    {
      "code": "FGE",
      "deviceName": "Stents, Drains And Dilators For The Biliary Ducts",
      "clearances": 22,
      "latest": "2018-05-01",
      "medianReviewDays": 70
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 20,
      "latest": "2021-02-16",
      "medianReviewDays": 210
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 15,
      "latest": "2019-03-22",
      "medianReviewDays": 261
    },
    {
      "code": "KRA",
      "deviceName": "Catheter, Continuous Flush",
      "clearances": 14,
      "latest": "2019-04-25",
      "medianReviewDays": 82
    },
    {
      "code": "FAD",
      "deviceName": "Stent, Ureteral",
      "clearances": 13,
      "latest": "2019-04-23",
      "medianReviewDays": 266
    },
    {
      "code": "FOZ",
      "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
      "clearances": 13,
      "latest": "2019-05-17",
      "medianReviewDays": 218
    },
    {
      "code": "KRD",
      "deviceName": "Device, Vascular, For Promoting Embolization",
      "clearances": 13,
      "latest": "2016-08-03",
      "medianReviewDays": 140
    },
    {
      "code": "LIT",
      "deviceName": "Catheter, Angioplasty, Peripheral, Transluminal",
      "clearances": 13,
      "latest": "2017-02-13",
      "medianReviewDays": 116
    },
    {
      "code": "LJS",
      "deviceName": "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days",
      "clearances": 9,
      "latest": "2018-02-22",
      "medianReviewDays": 87
    },
    {
      "code": "LJE",
      "deviceName": "Catheter, Nephrostomy",
      "clearances": 8,
      "latest": "2020-01-29",
      "medianReviewDays": 238
    },
    {
      "code": "KNT",
      "deviceName": "Tubes, Gastrointestinal (And Accessories)",
      "clearances": 7,
      "latest": "2019-10-11",
      "medianReviewDays": 191
    },
    {
      "code": "MQF",
      "deviceName": "Catheter, Assisted Reproduction",
      "clearances": 7,
      "latest": "2019-05-17",
      "medianReviewDays": 188
    },
    {
      "code": "BWC",
      "deviceName": "Needle, Emergency Airway",
      "clearances": 6,
      "latest": "2017-02-17",
      "medianReviewDays": 146
    },
    {
      "code": "DTK",
      "deviceName": "Filter, Intravascular, Cardiovascular",
      "clearances": 6,
      "latest": "2016-07-22",
      "medianReviewDays": 86
    },
    {
      "code": "GEX",
      "deviceName": "Powered Laser Surgical Instrument",
      "clearances": 6,
      "latest": "2018-07-30",
      "medianReviewDays": 90
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 6,
      "latest": "1992-09-23",
      "medianReviewDays": 90
    },
    {
      "code": "JOH",
      "deviceName": "Tube Tracheostomy And Tube Cuff",
      "clearances": 6,
      "latest": "2019-12-12",
      "medianReviewDays": 63
    },
    {
      "code": "LQR",
      "deviceName": "Dislodger, Stone, Biliary",
      "clearances": 6,
      "latest": "2018-03-01",
      "medianReviewDays": 69
    },
    {
      "code": "CBI",
      "deviceName": "Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)",
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      "latest": "2016-08-02",
      "medianReviewDays": 152
    },
    {
      "code": "KOD",
      "deviceName": "Catheter, Urological",
      "clearances": 5,
      "latest": "2018-06-28",
      "medianReviewDays": 241
    },
    {
      "code": "LKF",
      "deviceName": "Cannula, Manipulator/Injector, Uterine",
      "clearances": 5,
      "latest": "2019-03-29",
      "medianReviewDays": 266
    },
    {
      "code": "EZN",
      "deviceName": "Dilator, Catheter, Ureteral",
      "clearances": 4,
      "latest": "2018-07-17",
      "medianReviewDays": 119
    },
    {
      "code": "MMX",
      "deviceName": "Device, Percutaneous Retrieval",
      "clearances": 4,
      "latest": "2023-05-16",
      "medianReviewDays": 127
    }
  ],
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  "productCodesTotal": "92",
  "recentClearances": [
    {
      "kNumber": "K233177",
      "deviceName": "Nest VT Vitrification Device",
      "productCode": "MQK",
      "decisionDate": "2024-03-08",
      "reviewDays": 162
    },
    {
      "kNumber": "K222254",
      "deviceName": "Gunther Tulip Vena Cava Filter Retrieval Set",
      "productCode": "MMX",
      "decisionDate": "2023-05-16",
      "reviewDays": 293
    },
    {
      "kNumber": "K223098",
      "deviceName": "Bakri Essential Postpartum Balloon",
      "productCode": "OQY",
      "decisionDate": "2022-10-28",
      "reviewDays": 28
    },
    {
      "kNumber": "K210734",
      "deviceName": "Endovascular Dilator and Sets",
      "productCode": "DRE",
      "decisionDate": "2021-04-06",
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    },
    {
      "kNumber": "K203670",
      "deviceName": "Extra Large Check-Flo Introducer",
      "productCode": "DYB",
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    },
    {
      "kNumber": "K191498",
      "deviceName": "Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc",
      "productCode": "LJE",
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    },
    {
      "kNumber": "K190903",
      "deviceName": "Lawson Retrograde Nephrostomy Wire Puncture Set",
      "productCode": "LJE",
      "decisionDate": "2019-12-16",
      "reviewDays": 252
    },
    {
      "kNumber": "K193133",
      "deviceName": "Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set",
      "productCode": "JOH",
      "decisionDate": "2019-12-12",
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    },
    {
      "kNumber": "K191163",
      "deviceName": "Lumax Guiding Catheter",
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    },
    {
      "kNumber": "K190084",
      "deviceName": "McLean-Ring Enteral Feeding Tube Set",
      "productCode": "KNT",
      "decisionDate": "2019-10-11",
      "reviewDays": 267
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  "nameVariants": {
    "total": "11",
    "shown": [
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        "name": "COOK INCORPORATED",
        "dataset": "device/registrationlisting",
        "method": "normalised"
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        "name": "COOK, INC.",
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      {
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      {
        "name": "Cook Inc.",
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        "name": "Cook Incorporated",
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        "method": "normalised"
      },
      {
        "name": "Cook Incorporated",
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      },
      {
        "name": "Cook Incorporated",
        "dataset": "device/recall",
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      {
        "name": "Cook Incorporated",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Cook%20Incorporated%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Cook%20Incorporated%22"
  },
  "provenance": [
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      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
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  "retrievedAt": "2026-08-11T14:48:53.022Z"
}