# K031773: Endo Gator System

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Jun 24, 2003 after 15 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: 1 generation back to K884836 (1988). 2 ancestors in all.
58 later devices descend from it; 5 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971125: Endo Smartcap (100501), Endo Smart Cap Co. (1997) Summary page 4.
- K884836: Universal Generator Irrigator Model Ugi-3000, Meditron Devices, Inc. (1988) Summary page 4.

## Most influential descendants
- K092429: Endogator (2009), 41 descendants of its own
- K091305: Clearpath (2009), 13 descendants of its own
- K093779: Clearpath Ugi (2010), 10 descendants of its own
- K113050: Clearpath Lower GI (2012), 8 descendants of its own
- K220395: EndoGator Endoscopy Irrigation Tubing (2022), 7 descendants of its own

## Indications for use
The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units. The Endo Gator Cartridge is inlended as a replacement cartridge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap. The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.

Source page: https://510kreport.com/device/K031773
Methodology: https://510kreport.com/methodology