FDA 510(k)

EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes

Número K: K261274 · 2026-07-24

Data da decisão2026-07-24

Código do produtoKTI

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K261274. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes?

EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K261274.

When did EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes receive FDA 510(k) clearance?

EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261274.

Who is the listed applicant for EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes?

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

What is the FDA product code for EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes?

The FDA product code for EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes is KTI.

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Outros registros que listam Cook Ireland, Ltd. como candidato(a)

K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)K213946Compass BDS Biliary Stent K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle K182980Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

Ver todos os 16 dispositivos →

Dispositivos Relacionados (Código: KTI)

K251478ClearTip TBNA TypeFinemedix Co., 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 Corporation K250263Disposable Grasping Forceps FG-52D/FG-54DOlympus Medical Systems Corp.

Fonte oficial

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