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510(k) K123768

RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM by STERIS Corporation — Product Code NZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2013
Date Received
December 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

High level disinfection of reusable, heat-sensitive devices 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).

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  • K102244 — RELIANCE ENDOSCOPE PROCESSING SYSTEM (December 3, 2010)
  • K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (December 17, 2004)
  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
  • K841331 — OLYMPUS KC-10 MOBILE DISINFEC-STAT (July 19, 1984)