K760253 is an FDA 510(k) clearance for the TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1976, 35 days after receiving the submission on July 19, 1976.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K760253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1976 |
| Decision Date | August 23, 1976 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GBM — Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |