# K110088: Defendo Y-Opsy Irrigator

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical Incorporated
- Decided: Jun 10, 2011 after 149 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: 3 generations back to K884836 (1988). 6 ancestors in all.
2 later devices descend 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)
- K092429: Endogator, Byrne Medical, Inc. (2009) Summary page 1.
- 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 1.

## Most influential descendants
- K200481: Andorate Biopsy Valve, Andorate Biopsy Irrigator (2020), 1 descendant of its own
- K230932: ANDORATE® Valve Kit (2023), 0 descendants of its own

## Indications for use
The DEFENDOTM Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

Source page: https://510kreport.com/device/K110088
Methodology: https://510kreport.com/methodology