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FDA 510(k)

MIRA Surgical System

N.º K: K260817 · 2026-08-20

SolicitanteVirtual Incision
Fecha de decisión2026-08-20
Código de productoSAB
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

MIRA Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Virtual Incision. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K260817. The device is classified under product code SAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MIRA Surgical System?

MIRA Surgical System is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Virtual Incision. The 510(k) number is K260817.

When did MIRA Surgical System receive FDA 510(k) clearance?

MIRA Surgical System received FDA 510(k) clearance on 2026-08-20, under 510(k) number K260817.

Who is the listed applicant for MIRA Surgical System?

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

What is the FDA product code for MIRA Surgical System?

The FDA product code for MIRA Surgical System is SAB.

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Fuente oficial

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