{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "San Jose",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "2200 Zanker Rd., Unit F",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QKA",
      "openfda": {
        "device_name": "Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia",
        "medical_specialty_description": "Gastroenterology, Urology",
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      "applicant": "Prodeon Medical, Inc.",
      "decision_date": "2026-06-22",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Urocross Expander System (UES-2018-C1)",
      "advisory_committee": "GU",
      "contact": "Elaine  Aplaon",
      "expedited_review_flag": "",
      "k_number": "K261342",
      "state": "CA",
      "date_received": "2026-04-23",
      "review_advisory_committee": "GU",
      "postal_code": "95131",
      "decision_description": "Substantially Equivalent",
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}