# K160567: Barone Jejunostomy Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 18, 2017 after 444 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: 2 generations back to K880767 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991668: Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12), Novartis Nutrition Corp. (1999) Summary page 4.
- K925102: Flexiflo Laparoscopic Jejunostomy Kit, Abbott Laboratories (1994) Summary page 4.

## Indications for use
The Barone Jejunostomy Catheter Set is intended for patients older than 12 years old requiring jejunal feeding and delivery of medication. The device can be placed via a surgically open or laparoscopic technique.

Source page: https://510kreport.com/device/K160567
Methodology: https://510kreport.com/methodology