K171357 is an FDA 510(k) clearance for the SurgiMend PRS Meshed, Revize-X. This device is classified as a Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (Class II - Special Controls, product code OXH).
Submitted by Integra Lifesciences Corporation (Owner of Tei Biosciences) (Boston, US). The FDA issued a Cleared decision on June 7, 2017, 29 days after receiving the submission on May 9, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery..
| 510(k) Number | K171357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2017 |
| Decision Date | June 07, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXH — Mesh, Surgical, Collagen, 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. |