Modification to System 83 Plus

• • Terminated Z-0426-2014 FDA Class II ·initiated 12 Mar 2013 ·via K983017, on the same 510(k)

  Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

• • Terminated Z-1182-2008 FDA Unclassified (pre-2012) ·initiated 11 Feb 2008 ·via K983017, on the same 510(k)

  Inadvertent selection of the "wash" cycle

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K983017 ↗

FDA Product Code

NVE

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Scope-Assist Flushing Sink

  Class II

  FDA 510(k) K162120 Active Cleared 28 Apr 2017

• Custom Ultrasonics-Sys 80, 81-24, 83-2

  Class I

  FDA 510(k) K842754 Active Cleared 28 Nov 1984

• System 83 Plus Miniflex Washer-Disinfector

  Class II

  FDA 510(k) K061430 Active Cleared 12 Jan 2007

• System 83 Plus

  Class II

  FDA 510(k) K122172 Active Cleared 25 Jan 2013

• System 83 Plus Washer/Disinfector

  Class II

  FDA 510(k) K173590 Active Cleared 30 Mar 2020