K163217 is an FDA 510(k) clearance for the GORE BIO-A Tissue Reinforcement. This device is classified as a Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (Class II - Special Controls, product code OXF).
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on February 10, 2017, 86 days after receiving the submission on November 16, 2016.
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 | K163217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2016 |
| Decision Date | February 10, 2017 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| 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. |