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FDA 510(k)

Single Use Electrosurgical knife

K-Number: K171158 · 2017-11-17

ApplicantOlympus Medical Systems Corp.
Decision Date2017-11-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Electrosurgical knife is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2017-11-17 under approval number K171158. 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 Electrosurgical knife?

Single Use Electrosurgical knife is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K171158.

When was Single Use Electrosurgical knife approved by the FDA?

Single Use Electrosurgical knife received FDA 510(k) clearance on 2017-11-17, under approval number K171158.

What company makes Single Use Electrosurgical knife?

Single Use Electrosurgical knife is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Electrosurgical knife?

The FDA product code for Single Use Electrosurgical knife is KNS.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

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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. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus 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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