# K102796: Angiodynamics, Inc. Venacure Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Dec 15, 2010 after 79 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K133561: Venacure Evlt Nevertouch Procedure Kit, Venacure Evlt Tre' Sheath (2013), 1 descendant of its own
- K142614: AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits (2014), 0 descendants of its own

## Recalls of this device
- Apr 30, 2013 · Class II · Z-1406-2013: AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit coul
- Nov 10, 2011 · Not classified · Z-0400-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0401-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0407-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0411-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0402-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0406-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0408-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0412-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0414-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0403-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0404-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0405-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0409-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0410-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br
- Nov 10, 2011 · Not classified · Z-0413-2012: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to br

## Indications for use
The AngloDynamnics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Source page: https://510kreport.com/device/K102796
Methodology: https://510kreport.com/methodology