510(k) K203277 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Apr 28, 2021 |
| Received | Nov 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PK Cutting Forceps, 5mm 33cm
Product Name: PK Cutting Forceps
Model/Catalog Number: PK-CF0533
Product Description: An assembly of devices intended to generate and apply radio-frequ Open, Classified |
GEI | None listed |
| Aug 19, 2025 | Olympus Corporation of the Americas Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C.
The ESG-410 Electrosurgical Generator is an electrosurgical generator which utili Open, Classified |
GEI | None listed |
| Jul 23, 2024 | Olympus Corporation of the Americas ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries
Model/Catalog Number: Open, Classified |
GEI | None listed |
| Feb 20, 2024 | Olympus Corporation of the Americas ESG PK CUTTING FORCEPS, 5MM, 33CM Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.