{
  "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": "Hangzhou",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "8/F, 4th Bldg.,#2959 Yuhangtang Rd.,Cangqian St.",
      "address_2": "Yuhang District,Hangzhou, Zhejiang, 311121, China",
      "statement_or_summary": "Summary",
      "product_code": "OAB",
      "openfda": {
        "registration_number": [
          "3016020790",
          "3017185164",
          "3040004547",
          "3008849319",
          "1000523114",
          "2244478",
          "3021023752",
          "3043527620",
          "2031093",
          "9611854",
          "3017448139",
          "1721676",
          "3015540957",
          "1319211",
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          "3008849319",
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          "3017448139",
          "3001236549",
          "1721676",
          "3015540957",
          "1319211",
          "3017892510"
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        "device_name": "Low Energy Direct Current Thermal Ablation System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      },
      "zip_code": "311121",
      "applicant": "Hangzhou Ruidi Biotechnology , Ltd.",
      "decision_date": "2026-08-12",
      "decision_code": "SESE",
      "country_code": "CN",
      "device_name": "Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)",
      "advisory_committee": "SU",
      "contact": "Siran  Wu",
      "expedited_review_flag": "",
      "k_number": "K253846",
      "state": "",
      "date_received": "2025-12-02",
      "review_advisory_committee": "SU",
      "postal_code": "311121",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}