{
  "format": "devicerts.device.v1",
  "cite_as": "ClearTip TBNA Type, Finemedix Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/cleartip-tbna-type-kti (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/cleartip-tbna-type-kti.json",
    "markdown_url": "https://devicerts.com/devices/cleartip-tbna-type-kti.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
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        "url": "https://ec.europa.eu/tools/eudamed"
      }
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    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/cleartip-tbna-type-kti",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "ClearTip TBNA Type",
    "registry_name": "ClearTip TBNA Type",
    "url": "https://devicerts.com/devices/cleartip-tbna-type-kti",
    "manufacturer": {
      "name": "Finemedix Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/finemedix-co-ltd",
      "country": "South Korea",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "detail": "European Union and United States"
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    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
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        "values": [
          {
            "value": "K251478",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KTI"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The ClearTip Transbronchial Needle Aspiration (TBNA) is a bronchoscope accessory designed for transbronchial needle aspiration procedures. It facilitates the collection of tissue samples from mediastinal and hilar lymph nodes, aiding in the diagnosis of conditions such as lymphoma, infections, or malignancies within the thoracic cavity.\n\nThis device is supplied as a single-use, sterile accessory compatible with flexible bronchoscopes. It is intended for use in clinical settings such as operating rooms or bronchoscopy suites, adhering to standard aseptic techniques. The device is classified under FDA regulation 874.4680 as a Class II medical device, with FDA 510(k) clearance and MDR authorization. Multiple registration numbers and FEI numbers are associated with its regulatory submissions.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K251478",
      "number_label": null,
      "device_udi_di": null,
      "date": "2026-04-16",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
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    }
  ],
  "no_longer_listed_by": [],
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  "properties": [
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          "label": "510(k) Number",
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              "value": "K251478",
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      ]
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    {
      "group": "Classification",
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        {
          "label": "Device class",
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            {
              "value": "Class II",
              "registries": [
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 874.4680",
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            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ear, Nose, Throat",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
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        {
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}