{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Novato",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "385 Bel Marin Keys Blvd. #J",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "EXJ",
      "openfda": {
        "registration_number": [
          "3042277801",
          "1423537",
          "3008489813",
          "2938651",
          "3009308092",
          "1921846",
          "3001650535",
          "9613418",
          "9612030",
          "3005273623",
          "3003965134"
        ],
        "fei_number": [
          "3042277801",
          "3001236905",
          "3001044237",
          "3008489813",
          "2938651",
          "3009308092",
          "1921846",
          "3001650535",
          "3005273623",
          "3003965134",
          "3002806934"
        ],
        "device_name": "Device, Incontinence, Urosheath Type, Sterile",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5250",
        "device_class": "1"
      },
      "zip_code": "94949",
      "applicant": "Advanced Care Medical Products",
      "decision_date": "1997-07-31",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)",
      "advisory_committee": "GU",
      "contact": "STEVEN  FAINSZTEIN",
      "expedited_review_flag": "",
      "k_number": "K972100",
      "state": "CA",
      "date_received": "1997-06-04",
      "review_advisory_committee": "GU",
      "postal_code": "94949",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}