K142326 is an FDA 510(k) clearance for the HP Tissue Matrix, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Lifecell Corporation (Branchburg, US). The FDA issued a Cleared decision on December 23, 2014, 125 days after receiving the submission on August 20, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K142326 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 20, 2014 |
| Decision Date | December 23, 2014 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| 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 |