{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Bloomington",
      "advisory_committee_description": "Unknown",
      "address_1": "750 Daniels Way",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LJE",
      "openfda": {
        "registration_number": [
          "3012649202",
          "3011689956",
          "3010273872",
          "3043337628",
          "3007146453",
          "3007156625",
          "3013557562",
          "2030624",
          "3007695959",
          "1644312",
          "3030087693",
          "1820334",
          "2183744",
          "3019946783",
          "3004111573",
          "1450395",
          "3004730544",
          "3017425975",
          "3033848208",
          "1000121056",
          "3030733800",
          "3006082230",
          "3005099803",
          "3003814961",
          "1647149",
          "1825146",
          "1225687",
          "1625425",
          "1225798",
          "3002807314",
          "3004859241",
          "3003790304",
          "3010155661",
          "3005941719",
          "2124215",
          "9681477",
          "1018233",
          "3012494290",
          "3012480535",
          "3005580113",
          "1000393132",
          "3035451914",
          "9610711",
          "3005987240",
          "1646831",
          "3023460764",
          "2126666",
          "9681260",
          "3010419931",
          "1828132",
          "3030446844",
          "3011050570",
          "3027260597"
        ],
        "fei_number": [
          "3012649202",
          "3002807111",
          "3011689956",
          "3010273872",
          "3043337628",
          "3007146453",
          "3001595430",
          "3013557562",
          "1820334",
          "3007695959",
          "3030087693",
          "2183744",
          "3001451463",
          "3019946783",
          "3004111573",
          "1450395",
          "3004730544",
          "3017425975",
          "3033848208",
          "1000121056",
          "1000117748",
          "3002806565",
          "3030733800",
          "3006082230",
          "3005099803",
          "3002807917",
          "3003814961",
          "1825146",
          "1000306139",
          "1625425",
          "3002807314",
          "3004859241",
          "1000160215",
          "3003790304",
          "3010155661",
          "3008133910",
          "2124215",
          "1018233",
          "3012494290",
          "3012480535",
          "3005580113",
          "1000393132",
          "3035451914",
          "3005987240",
          "3023460764",
          "2126666",
          "3000206435",
          "3010419931",
          "1828132",
          "3030446844",
          "3002807439",
          "3011050570",
          "3027260597"
        ],
        "device_name": "Catheter, Nephrostomy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      },
      "zip_code": "47404",
      "applicant": "Cook Incorporated",
      "decision_date": "2018-08-17",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Ultraxx Nephrostomy Balloon Catheter Set",
      "advisory_committee": "",
      "contact": "Minjin  Choi",
      "expedited_review_flag": "",
      "k_number": "K181713",
      "state": "IN",
      "date_received": "2018-06-28",
      "review_advisory_committee": "GU",
      "postal_code": "47404",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}