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FDA 510(k)

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI

K-Number: K220053 · 2022-02-04

ApplicantFujifilm Corporation
Decision Date2022-02-04
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2022-02-04 under approval number K220053. 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 Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Fujifilm Corporation. The 510(k) number is K220053.

When was Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI approved by the FDA?

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI received FDA 510(k) clearance on 2022-02-04, under approval number K220053.

What company makes Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is manufactured by Fujifilm Corporation.

What is the FDA product code for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

The FDA product code for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is KGE.

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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. 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.

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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