The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Oes Elite Ureteroscopes And Accessories.
| Device ID | K200369 |
| 510k Number | K200369 |
| Device Name: | OES Elite Ureteroscopes And Accessories |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
| Contact | Stefanie Weber |
| Correspondent | Christina Flores Olympus Surgical Technologies America 118 Turnpike Road Southborough, MA 01772 -2104 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-14 |
| Decision Date | 2020-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761086578 | K200369 | 000 |
| 04042761086387 | K200369 | 000 |
| 04042761086394 | K200369 | 000 |
| 04042761086400 | K200369 | 000 |
| 04042761086417 | K200369 | 000 |
| 04042761086424 | K200369 | 000 |
| 04042761086431 | K200369 | 000 |
| 04042761086448 | K200369 | 000 |
| 04042761086561 | K200369 | 000 |
| 04042761086363 | K200369 | 000 |