FDA 510(k)

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

N.º K: K190829 · 2019-12-19

SolicitanteWilson-Cook Medical Inc./Cook Endoscopy

Fecha de decisión2019-12-19

Código de productoFBK

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190829. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K190829.

When did Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) receive FDA 510(k) clearance?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190829.

Who is the listed applicant for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is FBK.

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Otros registros que enlistan a Wilson-Cook Medical Inc./Cook Endoscopy como solicitante

K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords K172288Fusion OMNI Sphincterotome K171993Zimmon Needle Knife Papillotome K171607Bronchi and Gastrointestinal Cytology Brush

Dispositivos relacionados (Código: FBK)

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

Fuente oficial

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