# K043027: Monarch, Transshaping Gastrostomy Tube, Model 9-XX20

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Technology, Inc.
- Decided: Dec 2, 2004 after 29 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

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

## Indications for use
The Monarch Tm G-Tube is to be used as a percutaneous 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 MonarchTM G-Tube can also deliver medication and allow for decompression of the stomach.

Source page: https://510kreport.com/device/K043027
Methodology: https://510kreport.com/methodology