# K082044: Ace Stapler, Model F0031

- Pathway: 510(k) (Traditional)
- Applicant: Barosense, Inc.
- Decided: May 11, 2010 after 662 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K972679 (1997). 14 ancestors in all.
2 later devices descend 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)
- K062875: Endogastric Stomaphyx Device and Accessories, Endogastric Solutions, Inc. (2007) Summary page 2.
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product, Lsi Solutions (2001)
- K073671: Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge, Ndo Surgical, Inc. (2008) Summary page 2.

## Most influential descendants
- K110829: Ace Stapler and Cartridge (2011), 1 descendant of its own
- K120147: Ace Stapler and Cartridge (2012), 0 descendants of its own

## Indications for use
The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

Source page: https://510kreport.com/device/K082044
Methodology: https://510kreport.com/methodology