FDA 510(k)

Stitch - Suture Wires and Tapes

N.º K: K253910 · 2026-08-22

SolicitanteGM Dos Reis Industria e Comercio Ltda.

Fecha de decisión2026-08-22

Código de productoGAT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stitch - Suture Wires and 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 2026-08-22 under 510(k) number K253910. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stitch - Suture Wires and Tapes?

Stitch - Suture Wires and Tapes is a medical device that received FDA 510(k) clearance on 2026-08-22. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K253910.

When did Stitch - Suture Wires and Tapes receive FDA 510(k) clearance?

Stitch - Suture Wires and Tapes received FDA 510(k) clearance on 2026-08-22, under 510(k) number K253910.

Who is the listed applicant for Stitch - Suture Wires and 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 - Suture Wires and Tapes?

The FDA product code for Stitch - Suture Wires and Tapes is GAT.

Ensayos clínicos relacionados

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

K262537Versalock Sterile Plating System K261406Versalock Proximal Tibial Plating System K260390Super Upper Limbs Versalock Plating System K254188Meniscus Versaflex K252664GMReis Suture Anchors K243905Stitch Cerclage – Suture Tapes

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Dispositivos relacionados (Código: GAT)

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC K254275HyperSuture All Green Extension LineThreadstone, LLC K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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.