The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Electrosurgical Generator Esg-410, Foot Switches, Pk Cutting Forceps.
| Device ID | K203277 |
| 510k Number | K203277 |
| Device Name: | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
| Contact | Jan-oliver Upmeier |
| Correspondent | Christina Flores Olympus Surgical Technologies America 118 Turnpike Road Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-06 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761086349 | K203277 | 000 |
| 04042761086332 | K203277 | 000 |
| 00821925035850 | K203277 | 000 |