K133251 is an FDA 510(k) clearance for the BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 9, 2014, 199 days after receiving the submission on October 22, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K133251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 22, 2013 |
| Decision Date | May 09, 2014 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |