510(k) K250187

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) by Olympus Medical Systems Corporation — Product Code KGE

K250187 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)". The FDA issued a decision of Substantially Equivalent on October 7, 2025. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.