# K200481: Andorate Biopsy Valve, Andorate Biopsy Irrigator

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Jun 18, 2020 after 112 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: 4 generations back to K884836 (1988). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R), Byrne Medical, Inc. (2009) Summary page 4.
- K110088: Defendo Y-Opsy Irrigator, Byrne Medical Incorporated (2011) Summary page 4.

## Most influential descendants
- K230932: ANDORATE® Valve Kit (2023), 0 descendants of its own

## Indications for use
The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial firom the biopsy port throughout the endoscopic procedure. The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope’s biopsy channel.

Source page: https://510kreport.com/device/K200481
Methodology: https://510kreport.com/methodology