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FDA 510(k)

Stitch Cerclage – Suture Tapes

K-Number: K243905 · 2025-08-14

Decision Date2025-08-14
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stitch Cerclage – Suture Tapes is a medical device manufactured by GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2025-08-14 under approval number K243905. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stitch Cerclage – Suture Tapes?

Stitch Cerclage – Suture Tapes is a medical device that received FDA 510(k) clearance on 2025-08-14. It is manufactured by GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K243905.

When was Stitch Cerclage – Suture Tapes approved by the FDA?

Stitch Cerclage – Suture Tapes received FDA 510(k) clearance on 2025-08-14, under approval number K243905.

What company makes Stitch Cerclage – Suture Tapes?

Stitch Cerclage – Suture Tapes is manufactured by GM Dos Reis Industria e Comercio Ltda..

What is the FDA product code for Stitch Cerclage – Suture Tapes?

The FDA product code for Stitch Cerclage – Suture Tapes is JDQ.

Other Devices by GM Dos Reis Industria e Comercio Ltda.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.