# K962043: Auto Suture Modified VCS Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Sep 23, 1996 after 118 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933887 (1993). 1 ancestor in all.
58 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933887: Implantable Clip, United States Surgical, A Division of Tyco Healthc (1993) Summary page 1.

## Most influential descendants
- K994160: Coalescent Surgical Sutured-Clip (2000), 55 descendants of its own
- K012317: Coalescent Surgical U-Clip (2001), 52 descendants of its own
- K013664: Coalescent Surgical U-Clip (2002), 44 descendants of its own
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories (2002), 43 descendants of its own
- K023125: Coalescent U-Clip- and Accessories (2002), 42 descendants of its own

## Recalls of this device
- Jun 22, 2016 · Class II · Z-2289-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
- Jun 22, 2016 · Class II · Z-2284-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
- Jun 22, 2016 · Class II · Z-2283-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use
- Jun 22, 2016 · Class II · Z-2286-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
- Jun 22, 2016 · Class II · Z-2285-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
- Jun 22, 2016 · Class II · Z-2287-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
- Jun 22, 2016 · Class II · Z-2288-2016: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

## Indications for use
The AUTO SUTURE* Modified VCS* Clip #* Applier is available in multiple sizes and has application in the closure of arteriotomies and venotomies, the attachment of synthetic vascular prosthesis, the creation of everting anastomosis in blood vessels and other small tubular structures, and for the approximation of prosthetic grafts and dural tissue.

Source page: https://510kreport.com/device/K962043
Methodology: https://510kreport.com/methodology