FDA 510(k)

Fusion OMNI Sphincterotome

Número K: K172288 · 2018-04-17

RequerenteWilson-Cook Medical Inc./Cook Endoscopy

Data da decisão2018-04-17

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fusion OMNI Sphincterotome 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 2018-04-17 under 510(k) number K172288. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fusion OMNI Sphincterotome?

Fusion OMNI Sphincterotome is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K172288.

When did Fusion OMNI Sphincterotome receive FDA 510(k) clearance?

Fusion OMNI Sphincterotome received FDA 510(k) clearance on 2018-04-17, under 510(k) number K172288.

Who is the listed applicant for Fusion OMNI Sphincterotome?

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 Fusion OMNI Sphincterotome?

The FDA product code for Fusion OMNI Sphincterotome is KNS.

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Outros registros que listam Wilson-Cook Medical Inc./Cook Endoscopy como candidato(a)

K190829Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)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 K171993Zimmon Needle Knife Papillotome K171607Bronchi and Gastrointestinal Cytology Brush

Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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