FDA 510(k)

Zimmon Needle Knife Papillotome

N.º K: K171993 · 2017-08-17

SolicitanteWilson-Cook Medical Inc./Cook Endoscopy

Fecha de decisión2017-08-17

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Zimmon Needle Knife Papillotome 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 2017-08-17 under 510(k) number K171993. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Zimmon Needle Knife Papillotome?

Zimmon Needle Knife Papillotome is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K171993.

When did Zimmon Needle Knife Papillotome receive FDA 510(k) clearance?

Zimmon Needle Knife Papillotome received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171993.

Who is the listed applicant for Zimmon Needle Knife Papillotome?

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 Zimmon Needle Knife Papillotome?

The FDA product code for Zimmon Needle Knife Papillotome is KNS.

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

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 K172288Fusion OMNI Sphincterotome 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

Fuente oficial

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