Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI— 510(k) K220053

Name: FDA 510(k) clearance K220053
Creator: U.S. Food and Drug Administration
Published: 2022-02-04

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K220053 for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI, Substantially Equivalent on 2022-02-04. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code KGE
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2022-01-06
Decision date: 2022-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.