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510(k) K122172

SYSTEM 83 PLUS by Custom Ultrasonics — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2013
Date Received
July 23, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Custom Ultrasonics

  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K162120 — Scope-Assist Flushing Sink (April 28, 2017)
  • K061430 — SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (January 12, 2007)
  • K983017 — MODIFICATION TO SYSTEM 83 PLUS (September 22, 1998)
  • K842754 — CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 (November 28, 1984)

Other clearances for product code FEB

  • K241168 — System 83 Revolve Endoscope Washer/Disinfector (December 19, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (June 30, 2023)
  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K201920 — Endoscope Reprocessor OER-Elite (September 1, 2020)
  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K190969 — ENDOSCOPE REPROCESSOR OER-Elite (July 9, 2019)
  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)