{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "West Chester",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "6033 Schumacher Park Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OCL",
      "openfda": {
        "device_name": "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2",
        "registration_number": [
          "1047843",
          "3008729892",
          "2182291",
          "1036836",
          "1721983",
          "2184009",
          "9616793",
          "1721676",
          "2954783",
          "3035387162",
          "3011706110",
          "3005012805",
          "3006451981",
          "2528981",
          "9616065",
          "1717344",
          "2133810",
          "1423662",
          "3008592544",
          "1319639",
          "2134265",
          "3009882464",
          "2028523",
          "2124215",
          "3008262715",
          "3026612481",
          "3018094310",
          "9611854",
          "2087259",
          "3003955307",
          "1928237"
        ],
        "fei_number": [
          "1047843",
          "2182291",
          "1036836",
          "1721676",
          "3035387162",
          "3011706110",
          "3005012805",
          "3006451981",
          "2528981",
          "1717344",
          "3008592544",
          "3000203066",
          "3003186357",
          "3009882464",
          "1000531402",
          "3002843919",
          "3002095335",
          "1000138054",
          "3008262715",
          "3026612481",
          "2124215",
          "3018094310",
          "3002807258",
          "3003381355",
          "3000215273",
          "1000116158",
          "1000125147",
          "1000064530",
          "3002807555",
          "3003955307",
          "1928237"
        ]
      },
      "zip_code": "45069",
      "applicant": "AtriCure, Inc.",
      "decision_date": "2006-07-12",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1",
      "advisory_committee": "SU",
      "contact": "ELSA C ABRUZZO",
      "expedited_review_flag": "",
      "k_number": "K061593",
      "state": "OH",
      "date_received": "2006-06-08",
      "review_advisory_committee": "CV",
      "postal_code": "45069",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}