# K120587: Amt T-Fastener Anchor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: May 25, 2012 after 88 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Source page: https://510kreport.com/device/K120587
Methodology: https://510kreport.com/methodology