K172545 is an FDA 510(k) clearance for the SERI Contour, a Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXF), submitted by Sofregen Medical, Inc. (Medford, US). The FDA issued a Cleared decision on September 22, 2017, 30 days after receiving the submission on August 23, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K172545 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 2017 |
| Decision Date | September 22, 2017 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXF — Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery. |