510(k) K231777 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | Jun 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2025 | Olympus Corporation of the Americas Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U.
The ESG-410 Electrosurgical Generator is an electro Open, Classified |
GEI | None listed |
| Oct 30, 2024 | Olympus Corporation of the Americas Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.