K101287 is an FDA 510(k) clearance for the TEPHAFLEX COMPOSITE MESH. This device is classified as a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II - Special Controls, product code OWT).
Submitted by Tepha, Inc. (Lexington, US). The FDA issued a Cleared decision on August 30, 2010, 115 days after receiving the submission on May 7, 2010.
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 | K101287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2010 |
| Decision Date | August 30, 2010 |
| Days to Decision | 115 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. |