FDA 510(k)

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

Número K: K161186 · 2016-06-29

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2016-06-29

Código do produtoKGE

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K161186. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K161186.

When did Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) receive FDA 510(k) clearance?

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

Who is the listed applicant for Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Fonte oficial

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