K910196 is an FDA 510(k) clearance for the BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS. This device is classified as a Catheter, Double Lumen Female Urethrographic (Class II - Special Controls, product code FGH).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on March 27, 1991, 70 days after receiving the submission on January 16, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K910196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1991 |
| Decision Date | March 27, 1991 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FGH — Catheter, Double Lumen Female Urethrographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |