# K012476: Monarch, Transshaping Gastrostomy Tube Model 9-2010

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Technology, Inc.
- Decided: Aug 31, 2001 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.
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 Monarch™ Transshaping Gastrostomy 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 patient who is unable to consume nutrition by conventional means. The device can also deliver medication and allow for decompression of the stomach.

Source page: https://510kreport.com/device/K012476
Methodology: https://510kreport.com/methodology