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FDA 510(k)

ClearTip TBNA Type

K-Number: K251478 · 2026-04-16

ApplicantFinemedix Co., Ltd.
Decision Date2026-04-16
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ClearTip TBNA Type is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K251478. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearTip TBNA Type?

ClearTip TBNA Type is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K251478.

When did ClearTip TBNA Type receive FDA 510(k) clearance?

ClearTip TBNA Type received FDA 510(k) clearance on 2026-04-16, under 510(k) number K251478.

Who is the listed applicant for ClearTip TBNA Type?

The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearTip TBNA Type?

The FDA product code for ClearTip TBNA Type is KTI.

Other records listing Finemedix Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250994ClearTip FNA and FNB TypesK242857ClearHemograsperK242134ClearCap Distal AttachmentK231267ClearTipK202616ClearCap Distal AttachmentK200217ClearEndoclip

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Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems CorporationK250263Disposable Grasping Forceps FG-52D/FG-54DOlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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