Vision Sciences Flexible ENT Scope

• 2 recalls, same reason

  • Terminated Z-0929-2012 FDA Unclassified (pre-2012) ·initiated 27 Dec 2011
  • Terminated Z-0928-2012 FDA Unclassified (pre-2012) ·initiated 27 Dec 2011

  Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.

510(k) Number

K100125 ↗

FDA Product Code

EOB

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Flexible Nasopharyngo-Laryngoscope and Endosheath

  Class II

  FDA 510(k) K942265 Active Cleared 22 Dec 1995

• Modification to Vision Sciences Endosheath System

  Class II

  FDA 510(k) K024095 Active Cleared 9 Jan 2003

• Vision-Sciences Cst-2000 Flexible Cystoscope with Slide-on Endosheath System

  Class II

  FDA 510(k) K040215 Active Cleared 15 Apr 2004

• Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, DPU-5000/DPU-5050 Video Processor

  Class II

  FDA 510(k) K102733 Active Cleared 18 May 2011

• Vision-Sciences Cst-5000 Video Cystoscope with Endosheath System

  Class II

  FDA 510(k) K072180 Active Cleared 18 Dec 2007

• Flexible Hysteroscope with Endosheath System

  Class II

  FDA 510(k) K071127 Active Cleared 16 Nov 2007

See all devices from Vision-Sciences, Inc. →