510(k) K171916

Single Use Hot Biopsy Forceps FD-231 by Olympus Medical Systems Corp. — Product Code KGE

K171916 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Hot Biopsy Forceps FD-231". The FDA issued a decision of Substantially Equivalent on October 13, 2017. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.