# K120268: Amid Stapler

- Pathway: 510(k) (Special)
- Applicant: Safestich Medical, LLC
- Decided: Feb 10, 2012 after 11 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: 2 generations back to K771177 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093253: Amid Stapler, Safestitch, LLC (2009) Summary page 1.

## Indications for use
The SafeStitch AMID Stapler® has application in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissue(s), including skin.

Source page: https://510kreport.com/device/K120268
Methodology: https://510kreport.com/methodology