{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "NVE",
      "openfda": {
        "k_number": [
          "K222543",
          "K043314",
          "K871712",
          "K203199",
          "K861821",
          "K983017",
          "K073112",
          "K222849",
          "K190081",
          "K862402",
          "K832458",
          "K200577"
        ],
        "registration_number": [
          "3013283620",
          "9680353",
          "2150060",
          "3007487007",
          "3005899764",
          "3015612252",
          "3013665681",
          "3001675293",
          "2518897"
        ],
        "fei_number": [
          "3013283620",
          "2150060",
          "3007487007",
          "3005899764",
          "3015612252",
          "3013665681",
          "1000080301",
          "3001675293",
          "3004097451"
        ]
      },
      "review_panel": "HO",
      "medical_specialty": "GU",
      "device_name": "Washer, Cleaner, Automated, Endoscope",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Gastroenterology, Urology",
      "device_class": "2",
      "definition": "This automated device is intended to be used to clean endoscopes.  Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system.  The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle.     If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).      The instrument is placed in a tray with each lumen end positioned in opposite sides   of the tray to allow enough detergent and rinsing water pass through the lumens of   the endoscopes.",
      "regulation_number": "876.1500",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}