TIGR Matrix Surgical Mesh
FDA 510(k) clearance K163005 · decided 2017-07-27
Clearance details
- K-number
- K163005
- Device name
- TIGR Matrix Surgical Mesh
- Applicant
- Novus Scientific AB
- Decision
- Substantially Equivalent
- Date received
- 2016-10-28
- Decision date
- 2017-07-27
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- OWT
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Phasix ST Umbilical Hernia Patch (K243241) | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 |
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| TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (K191749) | Novus Scientific AB | 2020-03-26 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| Phasix ST Mesh with Open Positioning System (K190185) | C.R. Bard, Inc. | 2019-06-12 |
| Phasix ST Mesh (K173143) | C.R. Bard, Inc. | 2018-04-25 |
| Phasix ST Mesh (K143380) | C.R. Bard, Inc. | 2015-06-05 |
| PHASIX PLUG AND PATCH (K120728) | C.R. Bard, Inc. | 2012-10-22 |
| TEPHAFLEX COMPOSITE MESH (K101287) | Tepha, Inc. | 2010-08-30 |
| GORE BIOABSORBABLE MESH (K033671) | W. L. Gore & Associates, Inc. | 2003-12-31 |
Recalls involving this device
No recalls on record reference this clearance.