The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Flexible Tip Thoracoscope/laparoscope.
| Device ID | K915857 |
| 510k Number | K915857 |
| Device Name: | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-27 |
| Decision Date | 1994-03-11 |