K112137 is an FDA 510(k) clearance for the COMFORTGLIDE INTERMITENT CATHETER. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 26, 2011, 31 days after receiving the submission on July 26, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K112137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 26, 2011 |
| Decision Date | August 26, 2011 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |