# K061386: Anchor Band Suturing System, Model SR-AB

- Pathway: 510(k) (Traditional)
- Applicant: Anulex Technologies, Inc.
- Decided: Jul 5, 2006 after 48 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: 2 generations back to K930738 (1994). 4 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042031: Opus Speedstitch Suture Device, Opus Medical, Inc. (2004) Summary page 1.
- K972911: Auto Suture*Endostitch* II** Suture Applier, United States Surgical, A Division of Tyco Healthc (1998) Summary page 1.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 1.

## Most influential descendants
- K062307: Xclose Tissue Repair System, Model SRS (2006), 9 descendants of its own
- K100572: Versaclose, Model VC-200-01 (2010), 7 descendants of its own
- K091432: Xclose Tissue Repair System, Model XC-200-01 (2009), 7 descendants of its own
- K111462: Fixate Tissue Band (2011), 6 descendants of its own
- K112849: Fixate Tissue Band (2011), 5 descendants of its own

## Indications for use
The Anchor Band Suturing System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

Source page: https://510kreport.com/device/K061386
Methodology: https://510kreport.com/methodology