K922527 is an FDA 510(k) clearance for the BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 14, 1994, 686 days after receiving the submission on May 28, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K922527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | May 28, 1992 |
| Decision Date | April 14, 1994 |
| Days to Decision | 686 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |