FDA 510(k)

Stitch Cerclage – Suture Tapes

N.º K: K243905 · 2025-08-14

SolicitanteGM Dos Reis Industria e Comercio Ltda.

Fecha de decisión2025-08-14

Código de productoJDQ

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K243905.

When did Stitch Cerclage – Suture Tapes receive FDA 510(k) clearance?

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

Who is the listed applicant for Stitch Cerclage – Suture Tapes?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Otros registros que enlistan a GM Dos Reis Industria e Comercio Ltda. como solicitante

K253910Stitch - Suture Wires and Tapes K262537Versalock Sterile Plating System K261406Versalock Proximal Tibial Plating System K260390Super Upper Limbs Versalock Plating System K254188Meniscus Versaflex K252664GMReis Suture Anchors

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Dispositivos relacionados (Código: JDQ)

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243344Arthrex FiberTape y TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.K230976Arthrex Radiopaque FiberTape Cerclage suturasArthrex, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.