# K223171: AquaPulse® Irrigation Tubing

- Pathway: 510(k) (Special)
- Applicant: Ga Health Company Limited
- Decided: Nov 10, 2022 after 30 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884836 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202560: AquaPulse Irrigation Tubing, Ga Health Company Limited (2020) Summary page 4.

## Indications for use
The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

Source page: https://510kreport.com/device/K223171
Methodology: https://510kreport.com/methodology