Clearance Summary
Stitch Cerclage Suture Tapes received FDA 510(k) clearance under submission number K243905, sponsored by GM Dos Reis Industria e Comercio Ltda.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-08-14.
- Submission: K243905
- Applicant / Sponsor: GM Dos Reis Industria e Comercio Ltda.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 2025-08-14
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.