# K171619: 14Fr Colon Decompression Set, Macon Colon Decompression Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Aug 1, 2017 after 60 days
- Product code: FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation)
- 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 K900035 (1990). 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)
- K900035: Wilson-Cook Colon Decompression Set, Wilson-Cook Medical, Inc. (1990) Summary page 5.

## Indications for use
This device is used for treatment of acute non-toxic megacolon, pseudo-obstruction (Ogilvie’s syndrome) and colonic strictures.

Source page: https://510kreport.com/device/K171619
Methodology: https://510kreport.com/methodology