# K073034: Amt Initial Placement GI Kit (E2418) and Amt Dilator Set (E2419)

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Mar 14, 2008 after 140 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- May 14, 2024 · Class II · Z-2238-2024: Devices were labelled with the incorrect guidewire labelling.

## Indications for use
Initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who requre 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/K073034
Methodology: https://510kreport.com/methodology