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FDA 510(k)

Fusion OMNI Sphincterotome

K-Number: K172288 · 2018-04-17

ApplicantWilson-Cook Medical Inc./Cook Endoscopy
Decision Date2018-04-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fusion OMNI Sphincterotome is a medical device manufactured by Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2018-04-17 under approval number K172288. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion OMNI Sphincterotome?

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

When was Fusion OMNI Sphincterotome approved by the FDA?

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

What company makes Fusion OMNI Sphincterotome?

Fusion OMNI Sphincterotome is manufactured by Wilson-Cook Medical Inc./Cook Endoscopy.

What is the FDA product code for Fusion OMNI Sphincterotome?

The FDA product code for Fusion OMNI Sphincterotome is KNS.

Other Devices by Wilson-Cook Medical Inc./Cook Endoscopy

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

Related Devices (Code: KNS)

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.

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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