# K981323: Compat Mini-G Replacement Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Novartis Nutrition Corp.
- Decided: Oct 9, 1998 after 179 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 K885339 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885339: Flow Thru 16,18,20,22 FR Replace. Gastro Tube Kit, Superior Healthcare Group, Inc. (1989) Summary page 1.

## Indications for use
The Novartis Nutrition COMPAT Mini-G Feeding Tube Kit provides for the delivery of enteral formula through an externally minimized feeding tube. This replacement tube is used when there exists an established, well healed and mature stoma tract communicating between the stomach and external body surface. Externally minimized or low profile feeding devices are used to minimize the exposure of the tube outside of the patient’s body and to provide an improved body image to the patient by concealing the feeding device under the clothing.

Source page: https://510kreport.com/device/K981323
Methodology: https://510kreport.com/methodology