K944391 is an FDA 510(k) clearance for the OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM, a Device, Cystometric, Hydraulic (Class II — Special Controls, product code FEN), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on February 7, 1995, 151 days after receiving the submission on September 9, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K944391 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEN — Device, Cystometric, Hydraulic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1620 |