K251807 is an FDA 510(k) clearance for the Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on March 6, 2026, 267 days after receiving the submission on June 12, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K251807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2025 |
| Decision Date | March 06, 2026 |
| Days to Decision | 267 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 |