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FDA 510(k)

ARION ARC System

K-Number: K253917 · 2026-04-10

ApplicantPlasma Surgical, Inc.
Decision Date2026-04-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the ARION ARC System?

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

When was ARION ARC System approved by the FDA?

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

What company makes ARION ARC System?

ARION ARC System is manufactured by Plasma Surgical, Inc..

What is the FDA product code for ARION ARC System?

The FDA product code for ARION ARC System is GEI.

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Official Source

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