The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Oes Laparoscopy System.
| Device ID | K923982 |
| 510k Number | K923982 |
| Device Name: | OLYMPUS OES LAPAROSCOPY SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Andrew Fleischacker |
| Correspondent | Andrew Fleischacker OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-07 |
| Decision Date | 1993-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14042761052693 | K923982 | 000 |
| 04042761006156 | K923982 | 000 |
| 04042761006125 | K923982 | 000 |
| 04042761031110 | K923982 | 000 |
| 04042761031103 | K923982 | 000 |
| 04042761030861 | K923982 | 000 |
| 04042761030854 | K923982 | 000 |
| 04042761030847 | K923982 | 000 |
| 04042761030830 | K923982 | 000 |
| 04042761030823 | K923982 | 000 |
| 04042761030816 | K923982 | 000 |
| 04042761030809 | K923982 | 000 |
| 04042761030793 | K923982 | 000 |
| 04042761030786 | K923982 | 000 |
| 04042761030779 | K923982 | 000 |
| 04042761024419 | K923982 | 000 |
| 04042761006163 | K923982 | 000 |
| 04042761006194 | K923982 | 000 |
| 04042761008808 | K923982 | 000 |
| 04042761008792 | K923982 | 000 |
| 04042761008785 | K923982 | 000 |
| 04042761008778 | K923982 | 000 |
| 04042761008761 | K923982 | 000 |
| 04042761029759 | K923982 | 000 |
| 04042761029599 | K923982 | 000 |
| 04042761029582 | K923982 | 000 |
| 04042761009515 | K923982 | 000 |
| 04042761009508 | K923982 | 000 |
| 04042761009492 | K923982 | 000 |
| 04042761009485 | K923982 | 000 |
| 04042761008983 | K923982 | 000 |
| 04042761008969 | K923982 | 000 |
| 04042761008860 | K923982 | 000 |
| 04042761008815 | K923982 | 000 |
| 04042761024372 | K923982 | 000 |