K102391 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 December 22, 2010, 121 days after receiving the submission on August 23, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K102391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 23, 2010 |
| Decision Date | December 22, 2010 |
| Days to Decision | 121 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 |