Endo Smartcap

• 7 recalls, same reason

  • Terminated Z-1777-2020 FDA Class II ·initiated 9 Oct 2019
  • Terminated Z-1772-2020 FDA Class II ·initiated 9 Oct 2019
  • Terminated Z-1776-2020 FDA Class II ·initiated 9 Oct 2019
  • Terminated Z-1778-2020 FDA Class II ·initiated 9 Oct 2019
  • Terminated Z-1775-2020 FDA Class II ·initiated 9 Oct 2019
  • Terminated Z-1774-2020 FDA Class II ·initiated 9 Oct 2019
  • Terminated Z-1773-2020 FDA Class II ·initiated 9 Oct 2019

  Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.

510(k) Number

K093665 ↗

FDA Product Code

FAJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Endo Gator System

  Class II

  FDA 510(k) K031773 Active Cleared 24 Jun 2003

• 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

• Irrigation Channel Tubing, Model 100135

  Class II

  FDA 510(k) K033695 Active Cleared 23 Dec 2003

See all devices from Byrne Medical, Inc. →