About This 510(k) Submission
K250187 is an FDA 510(k) clearance for the Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U), a Forceps, Biopsy, Electric (Class II — Special Controls, product code KGE), submitted by Olympus Medical Systems Corporation (Tokyo, JP). The FDA issued a Cleared decision on October 7, 2025, 258 days after receiving the submission on January 22, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.