K222919 is an FDA 510(k) clearance for the GORE® ENFORM Biomaterial. 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 and Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on December 19, 2022, 84 days after receiving the submission on September 26, 2022.
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 | K222919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | December 19, 2022 |
| Days to Decision | 84 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. |