Cleared Traditional

RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM

K123768 · STERIS Corporation · General Hospital

Jul 2013

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K123768 is an FDA 510(k) clearance for the RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM, a Accessories, Germicide, Cleaning, For Endoscopes (Class II — Special Controls, product code NZA), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 26, 2013, 231 days after receiving the submission on December 7, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K123768 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 2012
Decision Date	July 26, 2013
Days to Decision	231 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NZA — Accessories, Germicide, Cleaning, For Endoscopes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	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).