Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)— 510(k) K161186

Substantially Equivalent

Fujifilm Medical Systems U.S.A, Inc.

FDA 510(k) clearance K161186 for Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter), Substantially Equivalent on 2016-06-29. Applicant: Fujifilm Medical Systems U.S.A, Inc..

Clearance details

Applicant: Fujifilm Medical Systems U.S.A, Inc.
Product code: Code KGE
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-27
Decision date: 2016-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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