# K253917: ARION ARC System

- Pathway: 510(k) (Traditional)
- Applicant: Plasma Surgical, Inc.
- Decided: Apr 10, 2026 after 123 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936109 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121977: Plasmajet Neutral Plasma Surgery System, Plasma Surgical Limited (2012) Summary page 5.

## Indications for use
The ARION Argon Reposable Coagulator (ARC) System is a plasma surgery system intended for coagulation in open surgery.

Source page: https://510kreport.com/device/K253917
Methodology: https://510kreport.com/methodology