# K082396: Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 2, 2009 after 136 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K913469 (1991). 5 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060494: Easytac Anchor.  Easytac Delivery System, Medchannel, LLC (2006) Summary page 1.

## Most influential descendants
- K092483: Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018 (2009), 6 descendants of its own
- K132134: Optifix Absorbable Fixation System (2013), 4 descendants of its own
- K142873: OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners (2015), 3 descendants of its own
- K132698: Fastouch Fixation System (2014), 3 descendants of its own
- K162252: FasTouch Fixation System (2016), 2 descendants of its own

## Indications for use
The Davol Absorbable Fastener System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Source page: https://510kreport.com/device/K082396
Methodology: https://510kreport.com/methodology