FDA 510(k)

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

K-Nummer: K151474 · 2016-02-18

AntragstellerFujifilm Medical System U.S.A., Inc.

Entscheidungsdatum2016-02-18

ProduktcodeKGE

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K151474.

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

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

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

The FDA 510(k) record lists Fujifilm Medical System 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), Diathermic Slitter (ClutchCutter)?

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

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Weitere Einträge mit Fujifilm Medical System U.S.A., Inc. als Antragsteller

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Verwandte Geräte (Code: KGE)

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