# K900035: Wilson-Cook Colon Decompression Set

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Mar 7, 1990 after 64 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K171619: 14Fr Colon Decompression Set, Macon Colon Decompression Set (2017), 0 descendants of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0056-2007: The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.
- Oct 8, 2003 · Not classified · Z-0048-04: Product may be packaged with an incorrect instructions for use (IFU) booklet.

Source page: https://510kreport.com/device/K900035
Methodology: https://510kreport.com/methodology