Olympus Medical Systems Corp. · Class II · Cleared Mar 6, 2026
| K-number | K251807 |
| Device name | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR |
| Applicant | Olympus Medical Systems Corp. |
| Product code | KGE |
| Device class | Class II |
| Decision date | Mar 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
The Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, and FD-412LR are sterile, single-use instruments designed for use with endoscopes to cauterize, coagulate, and perform hemostasis in the digestive tract using high-frequency electrical current. Models FD-410LR and FD-412LR are for upper digestive tract use, while FD-411UR is for lower digestive tract use.
The subject devices differ from the predicate (Ensure Single-Use Coagulation Forceps) in cup opening width (4–6.5 mm vs. 6.3 mm), maximum outer diameter (2.75–3.1 mm vs. ≤2.7 mm), and rated high-frequency voltage (2900 Vp vs. 2300 Vp). Both are single-use, sterile, ETO-sterilized forceps with rotating distal ends and the same working length.
ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017, USP <51>, ISO 11135:2014, ISO 10993-7:2008, ISO 11607-1:2019, ISO 11607-7:2019, ASTM F1980-21, IEC 60601-1, IEC 60601-1-2, and IEC TR 60601-4-2.
The subject device has the same intended use and basic design as the predicate; differences in cup geometry, diameter, and voltage do not affect performance as verified by bench testing. Comprehensive biocompatibility, sterilization validation, electrical safety, mechanical testing, and coagulation/hemostasis testing demonstrate the subject device is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov