K883274 is an FDA 510(k) clearance for the SURGITEK (R) UROFLOW SYSTEM. This device is classified as a Device, Urine Flow Rate Measuring, Non-electrical, Disposable (Class II - Special Controls, product code FFG).
Submitted by Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on February 8, 1989, 189 days after receiving the submission on August 3, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K883274 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1988 |
| Decision Date | February 08, 1989 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFG — Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1800 |