K031332 is an FDA 510(k) clearance for the BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 15, 2003, 17 days after receiving the submission on April 28, 2003.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K031332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2003 |
| Decision Date | May 15, 2003 |
| Days to Decision | 17 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |