{
  "companyId": "59744",
  "slug": "cook-urological-inc-59744",
  "name": "Cook Urological, Inc.",
  "clearances": {
    "total": 104,
    "last12Months": 0,
    "first": "1986-10-24",
    "latest": "2011-05-06"
  },
  "medianReviewDays": 88,
  "productCodeCount": 53,
  "recalls": {
    "total": 6,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1162-2007",
        "productCode": "EZB",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2007-06-12",
        "reason": "Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed."
      },
      {
        "resNumber": "Z-0377-2007",
        "productCode": "FED",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2007-01-05",
        "reason": "Lack of assurance of sterility, as the packages may not have been sealed."
      },
      {
        "resNumber": "Z-0674-06",
        "productCode": "FAD",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2006-03-01",
        "reason": "Instructions for Use (IFU) booklet missing pages 5-12.  Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events.  One patient booklet lacked pages 3-6, & 55-58."
      },
      {
        "resNumber": "Z-1584-05",
        "productCode": "KOE",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2005-08-01",
        "reason": "Mislabeled as to size."
      },
      {
        "resNumber": "Z-0554-03",
        "productCode": "EZN",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2003-01-22",
        "reason": "Product is labeled sterile, but was not sterilized."
      }
    ]
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  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "KOD",
      "deviceName": "Catheter, Urological",
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      "latest": "1993-12-22",
      "medianReviewDays": 87
    },
    {
      "code": "EZN",
      "deviceName": "Dilator, Catheter, Ureteral",
      "clearances": 5,
      "latest": "2004-04-06",
      "medianReviewDays": 76
    },
    {
      "code": "FAD",
      "deviceName": "Stent, Ureteral",
      "clearances": 5,
      "latest": "1996-07-24",
      "medianReviewDays": 107
    },
    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
      "clearances": 5,
      "latest": "1996-01-22",
      "medianReviewDays": 88
    },
    {
      "code": "HET",
      "deviceName": "Laparoscope, Gynecologic (And Accessories)",
      "clearances": 5,
      "latest": "1998-04-10",
      "medianReviewDays": 231
    },
    {
      "code": "MQL",
      "deviceName": "Media, Reproductive",
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      "latest": "2006-08-17",
      "medianReviewDays": 74
    },
    {
      "code": "GCJ",
      "deviceName": "Laparoscope, General & Plastic Surgery",
      "clearances": 4,
      "latest": "1996-03-15",
      "medianReviewDays": 91
    },
    {
      "code": "LJE",
      "deviceName": "Catheter, Nephrostomy",
      "clearances": 4,
      "latest": "2003-02-27",
      "medianReviewDays": 62
    },
    {
      "code": "EZL",
      "deviceName": "Catheter, Retention Type, Balloon",
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      "latest": "2009-10-09",
      "medianReviewDays": 114
    },
    {
      "code": "GEX",
      "deviceName": "Powered Laser Surgical Instrument",
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      "latest": "2008-04-17",
      "medianReviewDays": 51
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    {
      "code": "KNA",
      "deviceName": "Instrument, Manual, Specialized Obstetric-Gynecologic",
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      "latest": "2011-05-06",
      "medianReviewDays": 281
    },
    {
      "code": "EYB",
      "deviceName": "Catheter, Ureteral, Gastro-Urology",
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      "latest": "1996-06-11",
      "medianReviewDays": 20
    },
    {
      "code": "FAP",
      "deviceName": "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device",
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      "medianReviewDays": 76
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    {
      "code": "FBK",
      "deviceName": "Endoscopic Injection Needle, Gastroenterology-Urology",
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      "latest": "2008-09-25",
      "medianReviewDays": 43
    },
    {
      "code": "FED",
      "deviceName": "Endoscopic Access Overtube, Gastroenterology-Urology",
      "clearances": 2,
      "latest": "2005-03-31",
      "medianReviewDays": 108
    },
    {
      "code": "FHA",
      "deviceName": "Clamp, Penile",
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      "latest": "1990-02-16",
      "medianReviewDays": 115
    },
    {
      "code": "HFC",
      "deviceName": "Aspirator, Endocervical",
      "clearances": 2,
      "latest": "1996-08-29",
      "medianReviewDays": 187
    },
    {
      "code": "HHO",
      "deviceName": "Screw, Fibroid, Gynecological",
      "clearances": 2,
      "latest": "1992-05-18",
      "medianReviewDays": 168
    },
    {
      "code": "KOA",
      "deviceName": "Surgical Instruments, G-U, Manual (And Accessories)",
      "clearances": 2,
      "latest": "1993-07-02",
      "medianReviewDays": 88
    },
    {
      "code": "KOB",
      "deviceName": "Catheter, Suprapubic (And Accessories)",
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      "medianReviewDays": 50
    },
    {
      "code": "KOE",
      "deviceName": "Dilator, Urethral",
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      "latest": "1996-10-18",
      "medianReviewDays": 155
    },
    {
      "code": "LKF",
      "deviceName": "Cannula, Manipulator/Injector, Uterine",
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      "latest": "2004-10-01",
      "medianReviewDays": 87
    },
    {
      "code": "MQG",
      "deviceName": "Accessory, Assisted Reproduction",
      "clearances": 2,
      "latest": "2002-02-08",
      "medianReviewDays": 51
    },
    {
      "code": "MQH",
      "deviceName": "Microtools, Assisted Reproduction (Pipettes)",
      "clearances": 2,
      "latest": "2004-01-16",
      "medianReviewDays": 30
    },
    {
      "code": "OCZ",
      "deviceName": "Endoscopic Grasping/Cutting Instrument, Non-Powered",
      "clearances": 2,
      "latest": "1988-04-11",
      "medianReviewDays": 7
    }
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  "productCodesTotal": "53",
  "recentClearances": [
    {
      "kNumber": "K102141",
      "deviceName": "COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)",
      "productCode": "KNA",
      "decisionDate": "2011-05-06",
      "reviewDays": 281
    },
    {
      "kNumber": "K091767",
      "deviceName": "3 WAY SILICONE FOLEY BALLOON CATHETER",
      "productCode": "EZL",
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    {
      "kNumber": "K082939",
      "deviceName": "COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400",
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    {
      "kNumber": "K082066",
      "deviceName": "TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER",
      "productCode": "HFE",
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    {
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      "deviceName": "COOK WIRE GUIDES",
      "productCode": "OCY",
      "decisionDate": "2008-10-27",
      "reviewDays": 55
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      "kNumber": "K082319",
      "deviceName": "INJEKT FILIFORM INJECTION NEEDLE",
      "productCode": "FBK",
      "decisionDate": "2008-09-25",
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    },
    {
      "kNumber": "K080525",
      "deviceName": "COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W",
      "productCode": "GEX",
      "decisionDate": "2008-04-17",
      "reviewDays": 51
    },
    {
      "kNumber": "K073496",
      "deviceName": "OPTILITE HOLMIUM LASER FIBERS",
      "productCode": "GEX",
      "decisionDate": "2008-01-23",
      "reviewDays": 42
    },
    {
      "kNumber": "K072521",
      "deviceName": "COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH",
      "productCode": "FFS",
      "decisionDate": "2007-11-20",
      "reviewDays": 74
    },
    {
      "kNumber": "K061371",
      "deviceName": "SYDNEY IVF SPERM CRYOPRESERVATION BUFFER",
      "productCode": "MQL",
      "decisionDate": "2006-08-17",
      "reviewDays": 92
    }
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  "nameVariants": {
    "total": "2",
    "shown": [
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        "name": "Cook Urological, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
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        "name": "Cook Urological, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Cook%20Urological%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Cook%20Urological%2C%20Inc.%22"
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  "retrievedAt": "2026-08-11T14:48:53.043Z"
}