K202430 is an FDA 510(k) clearance for the Kerecis Reconstruct. This device is classified as a Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (Class II - Special Controls, product code OXH).
Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on May 2, 2021, 250 days after receiving the submission on August 25, 2020.
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 In Plastic And Reconstructive Surgery..
| 510(k) Number | K202430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2020 |
| Decision Date | May 02, 2021 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXH - Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery. |