# K982500: Chait Cecostomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jan 27, 1999 after 191 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 K851242 (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)
- K851242: Greco-Harvey Surfactant Bonded Catheter for Gastro, Cook, Inc. (1985) Summary page 2.

## Most influential descendants
- K180026: Bowel Management Device, Bowel Management Irrigation Set (2018), 0 descendants of its own

## Indications for use
The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening such as a cecostomy.

Source page: https://510kreport.com/device/K982500
Methodology: https://510kreport.com/methodology