# K231602: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Aug 1, 2023 after 61 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191366: Vacutore Air/Water Bottle Tubing, Smartdata Suzhou Co., Ltd. (2019) Summary page 5.
- K102855: Universal Irrigation Solution Hybrid, Byrne Medical, Inc. (2010) Summary page 5.

## Indications for use
The single use Protego Air Water Connector is intended to connect an air/C02 source, a sterile water source and an endoscope to supply air/C02 and water during gastrointestinal endoscopic procedures. Protego Air Water Bottle Tubing is to connect an air/C02 source, a sterile water source (water bottle), and an endoscope to supply air/C02 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device. Protego Hybrid Tubing is intended to connect an air/C02 source, a sterile water source and an endoscope to supply air/C02, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.

Source page: https://510kreport.com/device/K231602
Methodology: https://510kreport.com/methodology