The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera Elite Ii Video System Center, Visera Elite Ii Endoeye 3d.
| Device ID | K193026 |
| 510k Number | K193026 |
| Device Name: | Visera Elite II Video System Center, Visera Elite II Endoeye 3D |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Lisa M. Boyle Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| Subsequent Product Code | FET |
| Subsequent Product Code | GCM |
| Subsequent Product Code | HET |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-30 |
| Decision Date | 2020-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170386077 | K193026 | 000 |
| 04042761083492 | K193026 | 000 |
| 04042761083485 | K193026 | 000 |
| 04953170393112 | K193026 | 000 |
| 04953170386060 | K193026 | 000 |
| 04953170304927 | K193026 | 000 |
| 04953170304866 | K193026 | 000 |