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FDA 510(k)

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

K-Number: K160241 · 2016-03-02

ApplicantOlympus Medical Systems Corp.
Decision Date2016-03-02
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-03-02 under approval number K160241. 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 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K160241.

When was Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 approved by the FDA?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 received FDA 510(k) clearance on 2016-03-02, under approval number K160241.

What company makes Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

The FDA product code for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is KNS.

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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. 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. 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 cordsWilson-Cook Medical Inc./Cook Endoscopy

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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