510(k) K151474

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

K151474 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)". The FDA issued a decision of Substantially Equivalent on February 18, 2016. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.