K243302 is an FDA 510(k) clearance for the 3DMatrix DynaFlex (DynaFlex), a Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXF), submitted by Printbio, Inc. (Long Island City, US). The FDA issued a Cleared decision on May 21, 2025, 215 days after receiving the submission on October 18, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K243302 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 2024 |
| Decision Date | May 21, 2025 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXF — Mesh, Surgical, Absorbable, 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. |