{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Sunnyvale",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "452 Oakmead Pkwy.",
      "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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          "3016677053",
          "3013944123",
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          "3008791915",
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      "applicant": "Prodeon Medical, Inc.",
      "decision_date": "2026-03-12",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Urocross Expander System (Model Numbers ES2018 and ES3025)",
      "advisory_committee": "GU",
      "contact": "Elaine  Aplaon",
      "expedited_review_flag": "",
      "k_number": "K253525",
      "state": "CA",
      "date_received": "2025-11-13",
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      "postal_code": "94085",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}