K022011 is an FDA 510(k) clearance for the V.A.C. ABDOMINAL DRESSING, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 26, 2003, 252 days after receiving the submission on June 19, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K022011 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 19, 2002 |
| Decision Date | February 26, 2003 |
| Days to Decision | 252 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 |