The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for American Edwards Labs Flexiscope.
| Device ID | K841607 |
| 510k Number | K841607 |
| Device Name: | AMERICAN EDWARDS LABS FLEXISCOPE |
| Classification | Arthroscope |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-19 |
| Decision Date | 1984-08-18 |