# K112600: Angiodynamics, Inc. Venacure Nevertouch Direct Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jan 30, 2012 after 145 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130671: Venacure Evlt Nevertouch Procedure Kit (2013), 0 descendants of its own

## Recalls of this device
- Jun 27, 2019 · Class II · Z-2444-2019: The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser

## Indications for use
The AngioDynamics, Inc. VenaCure NeverTouch Direct Procedure Kit 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/K112600
Methodology: https://510kreport.com/methodology