# K062307: Xclose Tissue Repair System, Model SRS

- Pathway: 510(k) (Special)
- Applicant: Anulex Technologies, Inc.
- Decided: Sep 1, 2006 after 24 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.
9 later devices descend from it; 2 cite it directly.
0 of 15 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
- 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
- K113400: Fixate Tissue Band (2011), 4 descendants of its own
- K113805: Fixate Tissue Band (2012), 3 descendants of its own

## Indications for use
The XcloseTM Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

Source page: https://510kreport.com/device/K062307
Methodology: https://510kreport.com/methodology