# K033695: Irrigation Channel Tubing, Model 100135

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Dec 23, 2003 after 28 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: 2 generations back to K011016 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031773: Endo Gator System, Byrne Medical, Inc. (2003) Summary page 4.
- K024301: Lsi Endoscopic External Accessory Channel and Accessories Product, Lsi Solutions (2003) Summary page 4.

## Most influential descendants
- K092461: Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140 (2009), 0 descendants of its own

## Indications for use
The Byrne Medical Irrigation Channel Tubing is used with the Byrne Medical Endo Gator System and connects to the output tubing from the pump and goes down the channel of an Endoscope. The Byrne Medical Irrigation Channel Tubing is provided sterile and is labeled for single use only.

Source page: https://510kreport.com/device/K033695
Methodology: https://510kreport.com/methodology