K163005 is an FDA 510(k) clearance for the TIGR Matrix Surgical Mesh. This device is classified as a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II - Special Controls, product code OWT).
Submitted by Novus Scientific AB (Uppsala, SE). The FDA issued a Cleared decision on July 27, 2017, 272 days after receiving the submission on October 28, 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 During Hernia Repair..
| 510(k) Number | K163005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2016 |
| Decision Date | July 27, 2017 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| 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. |