# K080836: Modification to Endofast Reliant System

- Pathway: 510(k) (Special)
- Applicant: Endogun Medical Systems
- Decided: Apr 21, 2008 after 27 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931386 (1993). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060329: Endofast Reliant System, Endogun Medical Systems (2006) Summary page 1.

## Most influential descendants
- K130059: Endofast Reliant SCP, Endofast Reliant Lap (2013), 0 descendants of its own

## Indications for use
The EndoFast ReliantTM System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.

Source page: https://510kreport.com/device/K080836
Methodology: https://510kreport.com/methodology