K191773 is an FDA 510(k) clearance for the GORE BIO-A Tissue Reinforcement. This device is classified as a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II - Special Controls, product code OWT).
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on July 31, 2019, 29 days after receiving the submission on July 2, 2019.
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 During Hernia Repair..
| 510(k) Number | K191773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWT — Mesh, Surgical, Absorbable, Abdominal Hernia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair. |