FDA 510(k)

Valence InVent Xtend™ (CVG-4101-VXA)

N.º K: K253807 · 2026-08-20

SolicitanteConvergence Medical Sciences , Ltd.

Fecha de decisión2026-08-20

Código de productoMOD

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Valence InVent Xtend™ (CVG-4101-VXA) is the device name listed in this FDA 510(k) record. The listed applicant is Convergence Medical Sciences , Ltd.. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K253807. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Valence InVent Xtend™ (CVG-4101-VXA)?

Valence InVent Xtend™ (CVG-4101-VXA) is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Convergence Medical Sciences , Ltd.. The 510(k) number is K253807.

¿Cuándo recibió Valence InVent Xtend™ (CVG-4101-VXA) la aprobación 510(k) de la FDA?

Valence InVent Xtend™ (CVG-4101-VXA) received FDA 510(k) clearance on 2026-08-20, under 510(k) number K253807.

Who is the listed applicant for Valence InVent Xtend™ (CVG-4101-VXA)?

The FDA 510(k) record lists Convergence Medical Sciences , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Valence InVent Xtend™ (CVG-4101-VXA)?

The FDA product code for Valence InVent Xtend™ (CVG-4101-VXA) is MOD.

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Fuente oficial

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