# K100572: Versaclose, Model VC-200-01

- Pathway: 510(k) (Special)
- Applicant: Anulex Technologies, Inc.
- Decided: Mar 17, 2010 after 16 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930738 (1994). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061386: Anchor Band Suturing System, Model SR-AB, Anulex Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K111462: Fixate Tissue Band (2011), 6 descendants of its own
- K112849: Fixate Tissue Band (2011), 5 descendants of its own
- K113400: Fixate Tissue Band (2011), 4 descendants of its own
- K113805: Fixate Tissue Band (2012), 3 descendants of its own
- K150924: A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device (2015), 2 descendants of its own

## Indications for use
Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

Source page: https://510kreport.com/device/K100572
Methodology: https://510kreport.com/methodology