# K071191: Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit

- Pathway: 510(k) (Traditional)
- Applicant: Novartis Nutrition Corp.
- Decided: Jul 23, 2007 after 84 days
- Product code: FPD (Tube, Feeding)
- 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: 2 generations back to K853353 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965087: Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000), Sandoz Nutrition (1997) Summary page 1.

## Indications for use
The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding is used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.

Source page: https://510kreport.com/device/K071191
Methodology: https://510kreport.com/methodology