# K231418: ENDOGATOR™ Hybrid Irrigation Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Medivators
- Decided: Aug 14, 2023 after 90 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102855: Universal Irrigation Solution Hybrid, Byrne Medical, Inc. (2010) Summary page 5.

## Indications for use
The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

Source page: https://510kreport.com/device/K231418
Methodology: https://510kreport.com/methodology