K925790 is an FDA 510(k) clearance for the EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S. This device is classified as a Catheter, Upper Urinary Tract (Class II - Special Controls, product code EYC).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on May 17, 1993, 182 days after receiving the submission on November 16, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K925790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1992 |
| Decision Date | May 17, 1993 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EYC — Catheter, Upper Urinary Tract |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |