The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Instrument Tray, For Semi-rigid Ureteroscope.
| Device ID | K203492 |
| 510k Number | K203492 |
| Device Name: | Instrument Tray, For Semi-rigid Ureteroscope |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr, 61 Hamburg, DE 22045 |
| Contact | Jan-oliver Upmeier |
| Correspondent | Dolan Mills Olympus Surgical Technologies America 118 Turnpike Road Southborough, MA 01772 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761086608 | K203492 | 000 |