The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Model Fus-1, Flexible Ureteroscope.
| Device ID | K811535 |
| 510k Number | K811535 |
| Device Name: | MODEL FUS-1, FLEXIBLE URETEROSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-01 |
| Decision Date | 1981-06-23 |