510(k) K171096

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

K171096 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "Fujifilm Diathermic Slitter (FlushKnife)". The FDA issued a decision of Substantially Equivalent on May 9, 2017. 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.