# K213095: andorate Suction Valve, andorate Air/Water Valve

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Jan 12, 2022 after 110 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 5 generations back to K944759 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180341: FUJIFILM 600 Series Endoscope EG-600WR v2, Fujifilm Corporation (2018) Summary page 5.

## Indications for use
The single use andorate® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures. The single use andorate® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.

Source page: https://510kreport.com/device/K213095
Methodology: https://510kreport.com/methodology