Flexible Fiber Optic Endoscope

• • Terminated Z-1935-2011 FDA Unclassified (pre-2012) ·initiated 5 Oct 2010 ·on shared 510(k) K922826

  The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K922826 ↗

FDA Product Code

FGA

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Booster Trophy 5 Motorized Scooter

  Class II

  FDA 510(k) K955275 Active Cleared 4 Nov 1996

• Flexible Fiber Optic Gynecologic Endoscope

  Class II

  FDA 510(k) K922711 Active Cleared 17 May 1994

• Pl 20/20 Infant Vision Tester

  Class I

  FDA 510(k) K883337 Active Cleared 31 Oct 1988

• Flexible Fiber-Optic Nasopharyngoscope

  Class II

  FDA 510(k) K895245 Active Cleared 17 Nov 1989

• Booster Lite 4 Motorized Scooter

  Class II

  FDA 510(k) K955276 Active Cleared 4 Nov 1996

• Optiview

  Class II

  FDA 510(k) K972520 Active Cleared 29 Sep 1997

See all devices from Optimed Technologies, Inc. →

• What is the primary function of the Flexible Fiber Optic Endoscope?

  The Flexible Fiber Optic Endoscope is designed to provide illumination and access for the observation or manipulation of body cavities, hollow organs, and canals using fiber optic technology.

• Which medical specialties is this endoscope designed for?

  This device is intended for use within the medical specialties of gastroenterology and urology to facilitate visual examination of anatomical structures.

• What is the regulatory status of this device?

  The device is regulated under FDA 510(k) clearance number K922826, which indicates it has been found substantially equivalent to legally marketed predicate devices.