510(k) K161186

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) by Fujifilm Medical Systems U.S.A, Inc. — Product Code KGE

K161186 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)". The FDA issued a decision of Substantially Equivalent on June 29, 2016. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Fujifilm Medical Systems U.S.A, Inc. has at least 10 other 510(k) clearances on record.