The following data is part of a premarket notification filed by Surgitek with the FDA for Right Angle Urologic Laser Fiber.
| Device ID | K943491 |
| 510k Number | K943491 |
| Device Name: | RIGHT ANGLE UROLOGIC LASER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-08-05 |