K022350 is an FDA 510(k) clearance for the BARD CRURASOFT PATCH, MODELS 0116003 & 0116001. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by C.R. Bard, Inc. (Cranston, US). The FDA issued a Cleared decision on August 23, 2002, 35 days after receiving the submission on July 19, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K022350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2002 |
| Decision Date | August 23, 2002 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |