The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek Graduated Cystoscope (model Gc-16).
| Device ID | K904797 |
| 510k Number | K904797 |
| Device Name: | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) |
| Classification | Cystourethroscope |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Steve Aperavich |
| Correspondent | Steve Aperavich SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-23 |
| Decision Date | 1991-03-05 |