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FDA 510(k)

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

K-Number: K151474 · 2016-02-18

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2016-02-18
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is a medical device manufactured by Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2016-02-18 under approval number K151474. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)?

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K151474.

When was Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) approved by the FDA?

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) received FDA 510(k) clearance on 2016-02-18, under approval number K151474.

What company makes Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)?

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is manufactured by Fujifilm Medical System U.S.A., Inc..

What is the FDA product code for Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)?

The FDA product code for Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is KGE.

Other Devices by Fujifilm Medical System U.S.A., Inc.

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 K163675Processor VP-7000, Light Source BL-7000

Related Devices (Code: KGE)

K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC

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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