The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Endoeye Hd Ii (wa50040a, Wa50042a, Wa50050a, Wa50052a).
| Device ID | K190744 |
| 510k Number | K190744 |
| Device Name: | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) |
| Classification | Laparoscope, Gynecologic (and 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 -061 |
| Product Code | HET |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-22 |
| Decision Date | 2019-08-29 |