# K073464: Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure Kit

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Jan 23, 2008 after 44 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: 9 generations back to K943450 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071959: Angiodynamics, Inc.Nevertouch 600UM Fiber and Venacure Procedure Kit, AngioDynamics, Inc. (2007) Summary page 1.
- K040921: Cooltouch, Model NS 160, Cooltouch, Inc. (2004) Summary page 1.

## Indications for use
The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Source page: https://510kreport.com/device/K073464
Methodology: https://510kreport.com/methodology