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ClearTip TBNA Type

by Finemedix Co., Ltd.

510(k) K251478

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251478↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251478 Date16 Apr 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251478 decided 16 Apr 2026 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
KTI
Device class
Class II
Regulation
21 CFR Part 874.4680
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

This 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.

Similar devices

Other devices filed under FDA product code KTI (Bronchoscope Accessory).

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