The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Instrument Basket, For Endoeye.
| Device ID | K171692 |
| 510k Number | K171692 |
| Device Name: | Instrument Basket, For EndoEYE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
| Contact | Jan-oliver Upmeier |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway Center Valley, PA 18034 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-07 |
| Decision Date | 2018-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761067690 | K171692 | 000 |