# K954429: Kangaroo Entristar Skin-Level Gastrostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Mar 8, 1996 after 168 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 K923474 (1993). 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)
- K923474: Low Profile Gastromstomy Device, Biosearch Medical Products, Inc. (1993) Summary page 1.

## Indications for use
The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as a conduit for insertion of enteral access devices such as gastric decompression catheters or intestinally placed feeding catheters.

Source page: https://510kreport.com/device/K954429
Methodology: https://510kreport.com/methodology