{
  "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": "2026-08-31",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Mansfield",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "15 Hampshire St.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "FIE",
      "openfda": {
        "device_name": "Needle, Fistula",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2",
        "registration_number": [
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          "3003464075",
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        "fei_number": [
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          "1000132332",
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      },
      "zip_code": "02048",
      "applicant": "Mozarc Medical Us, LLC",
      "decision_date": "2026-08-06",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)",
      "advisory_committee": "GU",
      "contact": "Sara  Miller",
      "expedited_review_flag": "",
      "k_number": "K253469",
      "state": "MA",
      "date_received": "2025-10-10",
      "review_advisory_committee": "GU",
      "postal_code": "02048",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}