K163152 is an FDA 510(k) clearance for the PROLENE Soft Polypropylene Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 11, 2017, 121 days after receiving the submission on November 10, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K163152 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 10, 2016 |
| Decision Date | March 11, 2017 |
| Days to Decision | 121 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 |