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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) 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. The listed applicant is Fujifilm Corporation. The 510(k) number is K220053.

When did Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI receive FDA 510(k) clearance?

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

Who is the listed applicant for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

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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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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