K243905 is an FDA 510(k) clearance for the Stitch Cerclage – Suture Tapes. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on August 14, 2025, 238 days after receiving the submission on December 19, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K243905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2024 |
| Decision Date | August 14, 2025 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |