K920451 is an FDA 510(k) clearance for the ENDOTEK ULTRA SYSTEM, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on September 17, 1992, 226 days after receiving the submission on February 4, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K920451 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1992 |
| Decision Date | September 17, 1992 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1620 |