ERBEFLO 2 Disposable Tubing System

• • Ongoing Z-2064-2026 FDA Class II ·initiated 31 Mar 2026

  Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

510(k) Number

K190469 ↗

FDA Product Code

OCX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Erbe Model Vio 300 D with Accessories

  Class II

  FDA 510(k) K083452 Active Cleared 31 Dec 2008

• Erbotom Icc 50

  Class II

  FDA 510(k) K935815 Active Cleared 31 Mar 1994

• Erbe's Tubing/Cap Sets Open recall

  Class II

  FDA 510(k) K221177 Active Cleared 11 Aug 2022

• ERBECRYO 2 Cryosurgical Unit with accessories

  Class II

  FDA 510(k) K151041 Active Cleared 4 May 2015

• Erbeflo 2 Disposable Tubing System

  Class II

  FDA 510(k) K103235 Active Cleared 23 Dec 2010

• Erbe Esu Model Vio 100 C with Accessories

  Class II

  FDA 510(k) K101108 Active Cleared 16 Jul 2010

See all devices from Erbe USA, Inc. →