510(k) K220053

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI by Fujifilm Corporation — Product Code KGE

K220053 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI". The FDA issued a decision of Substantially Equivalent on February 4, 2022. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Fujifilm Corporation has at least 10 other 510(k) clearances on record.