{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Dublin",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "Unit 53 Guinness Enterprise Centre,",
      "address_2": "Taylors Ln., Dublin 8",
      "statement_or_summary": "Summary",
      "product_code": "OMT",
      "openfda": {
        "device_name": "Absorbable Lung Biopsy Plug",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4755",
        "device_class": "2",
        "registration_number": [
          "3006950086",
          "1721504",
          "3012536737",
          "3011642792",
          "1721676",
          "3015225571",
          "3033589330",
          "1724474",
          "3015309643",
          "2030624"
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          "3000206435",
          "1721504",
          "3012536737",
          "3011642792",
          "1721676",
          "3015225571",
          "3033589330",
          "3015309643",
          "3003094851"
        ]
      },
      "zip_code": "D08 R9YW",
      "applicant": "Selio Medical Limited",
      "decision_date": "2025-04-08",
      "decision_code": "SESE",
      "country_code": "IE",
      "device_name": "Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)",
      "advisory_committee": "SU",
      "contact": "Colm  McGarvey",
      "expedited_review_flag": "",
      "k_number": "K243722",
      "state": "",
      "date_received": "2024-12-03",
      "review_advisory_committee": "AN",
      "postal_code": "D08 R9YW",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}