# K181044: 400um Perforator and Accessory Vein Ablation Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jul 5, 2018 after 77 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers, Diomed, Inc. (2004) Summary page 4.
- K052003: Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40), Vnus Medical Technologies, Inc. (2005) Summary page 5.

## Indications for use
The 400m Perforator and Accessory Vein Ablation Kit is indicated for use in the treatment of superficial vein reflux of greater saphenous vein associated with varicosities. The 400m Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of Incompetent (i.e. refluxing) Perforator Veins (IPVs).

Source page: https://510kreport.com/device/K181044
Methodology: https://510kreport.com/methodology