{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "San Sebastian (Guipuzcoa)",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "C/Portuetxe 13, 1 C 20018",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "KPL",
      "openfda": {
        "device_name": "Colonic Irrigation System",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5220",
        "device_class": "2",
        "registration_number": [
          "3043011436",
          "3043012074",
          "3043012240",
          "9615415",
          "1320894",
          "1062839",
          "3022964615",
          "1223925",
          "3042228064",
          "3005346382",
          "2433012",
          "3007305485",
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          "1648139"
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          "3043012074",
          "1000516428",
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          "3042228064",
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          "3005346382",
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          "3007305485",
          "2027347"
        ]
      },
      "zip_code": "",
      "applicant": "Colonplus Equipments & Speculums, S.L.",
      "decision_date": "2016-08-10",
      "decision_code": "SESE",
      "country_code": "ES",
      "device_name": "Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10",
      "advisory_committee": "GU",
      "contact": "Jorge  Echevarria",
      "expedited_review_flag": "",
      "k_number": "K152834",
      "state": "",
      "date_received": "2015-09-29",
      "review_advisory_committee": "GU",
      "postal_code": "",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}