K250187 is an FDA 510(k) clearance for the Disposable Hot Biopsy Forceps (FD-210U). This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K250187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2025 |
| Decision Date | October 07, 2025 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE — Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |