# K965087: Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)

- Pathway: 510(k) (Traditional)
- Applicant: Sandoz Nutrition
- Decided: Mar 18, 1997 after 89 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 K853353 (1985). 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)
- K853353: 88000 Gastrostomy-Jejunal Feeding Tube Kit, Superior Healthcare Group, Inc. (1985). Our OCR of the scanned summary read K853351, FDA’s number for Ohmeda Heat Reflecting Patch (Ohmeda Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sandoz Nutrition #088000 Surgical Gastrostomy/Jejunostomy Feeding…”.

## Most influential descendants
- K071191: Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit (2007), 0 descendants of its own

## Indications for use
The Sandoz Nutrition Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding us 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/K965087
Methodology: https://510kreport.com/methodology