# K980868: GC Irrigator

- Pathway: 510(k) (Traditional)
- Applicant: Gentle Colonics, Inc.
- Decided: Aug 6, 1998 after 153 days
- Product code: KPL (Colonic Irrigation System)
- Device class: 2
- Regulation: 21 CFR 876.5220
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050992: Conmed Irrigation Nozzle (2005), 0 descendants of its own

## Indications for use
The GC Irrigator is intended for use for colon cleansing when medically indicated, such as before radiological or endoscopic examination. To be used with commercially available gravity flow colonic irrigation units.

Source page: https://510kreport.com/device/K980868
Methodology: https://510kreport.com/methodology