Cleared Special

Reliance Endoscope Processing System

K200989 · STERIS Corporation · General Hospital

May 2020

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K200989 is an FDA 510(k) clearance for the Reliance 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 May 14, 2020, 29 days after receiving the submission on April 15, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K200989 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2020
Decision Date	May 14, 2020
Days to Decision	29 days
Submission Type	Special
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).