The following data is part of a premarket notification filed by Surgitek with the FDA for Endotek Ultra System.
| Device ID | K920451 |
| 510k Number | K920451 |
| Device Name: | ENDOTEK ULTRA SYSTEM |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | William H Duffell |
| Correspondent | William H Duffell SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-04 |
| Decision Date | 1992-09-17 |