{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Maple Grove",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "One Scimed Pl.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "FAD",
      "openfda": {
        "device_name": "Stent, Ureteral",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4620",
        "device_class": "2",
        "registration_number": [
          "2527072",
          "1123137",
          "3021632375",
          "3011642792",
          "3009526575",
          "3012649202",
          "3024807849",
          "1825146",
          "2125050",
          "9681442",
          "2027111",
          "1018233",
          "3005580113",
          "3014246639",
          "3002807314",
          "9617744",
          "9681260",
          "1048735",
          "3015309643",
          "3005232773",
          "3005099803",
          "1225687",
          "3005987240",
          "3009051888",
          "3013023255",
          "3011050570",
          "3007156625",
          "3004859241",
          "1647149",
          "9610711",
          "1037955",
          "1000393132",
          "1313046",
          "3010131137",
          "3016678045",
          "3033848208",
          "1828132",
          "3012536737",
          "9611590",
          "3008797804",
          "3003814961",
          "1000121056",
          "2246552",
          "3010273872",
          "1820334",
          "2030624",
          "3003915875",
          "3007695959",
          "3005941719",
          "3006082230",
          "3033589330",
          "1646831",
          "3015225571",
          "3001845648",
          "9681477",
          "3013460719",
          "3030087693",
          "3010155661",
          "3003790304",
          "3016096097",
          "1721504",
          "2124215",
          "3009763019",
          "3012050423",
          "2183744",
          "3004365956",
          "3006950086",
          "2126666",
          "1424778",
          "3017210488"
        ],
        "fei_number": [
          "2527072",
          "3021632375",
          "3011642792",
          "3009526575",
          "3012649202",
          "3002806368",
          "3024807849",
          "1825146",
          "2125050",
          "2027111",
          "1018233",
          "3002807111",
          "3005580113",
          "1000160215",
          "3014246639",
          "3002807314",
          "1048735",
          "3017210488",
          "1000306139",
          "3015309643",
          "3005232773",
          "3005099803",
          "3005987240",
          "3009051888",
          "3013023255",
          "3011050570",
          "3004859241",
          "3002806565",
          "1037955",
          "1000393132",
          "3002807439",
          "1313046",
          "3010131137",
          "3016678045",
          "3033848208",
          "1828132",
          "3012536737",
          "1000123180",
          "3008797804",
          "1000237915",
          "1000121056",
          "2246552",
          "3003814961",
          "3010273872",
          "1820334",
          "3003915875",
          "3006082230",
          "3007695959",
          "3033589330",
          "3001451463",
          "3015225571",
          "3002807917",
          "3001845648",
          "3013460719",
          "3030087693",
          "3010155661",
          "3003790304",
          "3006279007",
          "3016096097",
          "1721504",
          "2124215",
          "3009763019",
          "3003473227",
          "3012050423",
          "3004365956",
          "3000206435",
          "2183744",
          "3006950086",
          "2126666",
          "3008133910"
        ]
      },
      "zip_code": "55311",
      "applicant": "Boston Scientific Corporation",
      "decision_date": "2022-11-10",
      "decision_code": "SESK",
      "country_code": "US",
      "device_name": "APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg",
      "advisory_committee": "GU",
      "contact": "Liz  Johnston",
      "expedited_review_flag": "",
      "k_number": "K211934",
      "state": "MN",
      "date_received": "2021-06-22",
      "review_advisory_committee": "GU",
      "postal_code": "55311",
      "decision_description": "Unknown",
      "clearance_type": "Traditional"
    }
  ]
}