FDA 510(k)

VenSure LightGuide

N.º K: K212774 · 2022-02-04

Fecha de decisión2022-02-04

Código de productoLRC

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

VenSure LightGuide is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Ent.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212774. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VenSure LightGuide?

VenSure LightGuide is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Intersect Ent.. The 510(k) number is K212774.

When did VenSure LightGuide receive FDA 510(k) clearance?

VenSure LightGuide received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212774.

Who is the listed applicant for VenSure LightGuide?

The FDA 510(k) record lists Intersect Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VenSure LightGuide?

The FDA product code for VenSure LightGuide is LRC.

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Fuente oficial

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