# K120147: Ace Stapler and Cartridge

- Pathway: 510(k) (Special)
- Applicant: Barosense, Inc.
- Decided: Feb 17, 2012 after 30 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: 8 generations back to K972679 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110829: Ace Stapler and Cartridge, Barosense, Inc. (2011)

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

Source page: https://510kreport.com/device/K120147
Methodology: https://510kreport.com/methodology