Cleared Traditional

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

K203223 · Steris · General Hospital

Jan 2021

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K203223 is an FDA 510(k) clearance for the Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide, a Accessories, Germicide, Cleaning, For Endoscopes (Class II — Special Controls, product code NZA), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on January 28, 2021, 87 days after receiving the submission on November 2, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K203223 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2020
Decision Date	January 28, 2021
Days to Decision	87 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).