K243843 is an FDA 510(k) clearance for the Tendon Protect (50242). This device is classified as a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWY).
Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on June 4, 2025, 173 days after receiving the submission on December 13, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair..
| 510(k) Number | K243843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2024 |
| Decision Date | June 04, 2025 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWY - Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair. |