# K980305: Amt Button Replacement Gastrostomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Apr 16, 1998 after 79 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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
Longest line of descent: 1 generation back to K843392 (1984). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843392: Gauderer Gastrostomy Button, American V. Mueller (1984) Summary page 1.
- (no number) Button and Replacement Button: named in the summary without a submission number
- (no number) Button and Replacement Button: named in the summary without a submission number

## Most influential descendants
- K170319: Low Profile Non-Balloon Feeding Device (2017), 0 descendants of its own

## Indications for use
The AMT Button Replacement Gastrostomy Device is to be used as a replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The AMT Button Replacement Gastrostomy Device can also deliver medication and allow for decompression of the stomach.

Source page: https://510kreport.com/device/K980305
Methodology: https://510kreport.com/methodology