{
  "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": "2026-09-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Suzhou",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "Unit 101, B8 Bldg., 218 Xinghu St. Suzhou Industrial Park",
      "address_2": "(Jiangsu) Pilot Free Trade Zone Suzhou Area",
      "statement_or_summary": "Summary",
      "product_code": "PLL",
      "openfda": {
        "device_name": "Submucosal Injection Agent",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "9681630",
          "3008720584",
          "3013440400",
          "3013911864",
          "1528319",
          "3008132411",
          "3013155768",
          "3006696607",
          "3014718111",
          "3012099114",
          "3005099803",
          "3004837686",
          "3013734919"
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        "fei_number": [
          "1000121355",
          "1000122656",
          "3008720584",
          "3013440400",
          "3013911864",
          "3008132411",
          "3013155768",
          "3006696607",
          "3002808845",
          "3012099114",
          "3005099803",
          "3004837686",
          "3013734919"
        ]
      },
      "zip_code": "215000",
      "applicant": "Endoclot Plus Co., Ltd.",
      "decision_date": "2026-09-09",
      "decision_code": "SESE",
      "country_code": "CN",
      "device_name": "SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)",
      "advisory_committee": "GU",
      "contact": "Huihui  Xie",
      "expedited_review_flag": "",
      "k_number": "K260997",
      "state": "",
      "date_received": "2026-03-26",
      "review_advisory_committee": "GU",
      "postal_code": "215000",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}