Endo Gator System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K031773 ↗

FDA Product Code

OCX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Endogator Endoscopy Irrigation Pump, Model Egp-100

  Class II

  FDA 510(k) K060962 Active Cleared 19 Apr 2006

• Defendo (Tm) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301, Defendo(Tm) Biopsy Valve for Pentax(R)

  Class II

  FDA 510(k) K090851 Active Cleared 2 Jul 2009

• Defendo Disposable Suction Valve Model 100305

  Class II

  FDA 510(k) K102581 Active Cleared 8 Nov 2010

• Endogater Avantage CO2 Insufflator

  Class II

  FDA 510(k) K113310 Active Cleared 20 Jun 2012

• Endo Smartcap

  Class II

  FDA 510(k) K093665 Active Cleared 15 Dec 2009

• Irrigation Channel Tubing, Model 100135

  Class II

  FDA 510(k) K033695 Active Cleared 23 Dec 2003

See all devices from Byrne Medical, Inc. →