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FDA 510(k)

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

K-Number: K161186 · 2016-06-29

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2016-06-29
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-06-29 under approval number K161186. 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), Fujifilm Diathermic Slitter (ClutchCutter)?

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) is a medical device that received FDA 510(k) clearance on 2016-06-29. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K161186.

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

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) received FDA 510(k) clearance on 2016-06-29, under approval number K161186.

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

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

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

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

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

K162622Fujifilm Endoscope Models EC-600HL and EC-600LS K153464FDR D-EVO flat Panel Detector System K160196Fujifilm Video Colonoscope Model EC-600WL V2 K160108Synapse PACS K173132ASPIRE Cristalle K171463ASPIRE Bellus II

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Related Devices (Code: KGE)

K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. 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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