FDA 510(k)

ARION ARC System

N.º K: K253917 · 2026-04-10

Fecha de decisión2026-04-10

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ARION ARC System is the device name listed in this FDA 510(k) record. The listed applicant is Plasma Surgical, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253917. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ARION ARC System?

ARION ARC System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Plasma Surgical, Inc.. The 510(k) number is K253917.

When did ARION ARC System receive FDA 510(k) clearance?

ARION ARC System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253917.

Who is the listed applicant for ARION ARC System?

The FDA 510(k) record lists Plasma Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARION ARC System?

The FDA product code for ARION ARC System is GEI.

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