Cleared Special

Endoscope Reprocessor OER-Elite

K201920 · Olympus Medical Systems Corp. · General Hospital

Sep 2020

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K201920 is an FDA 510(k) clearance for the Endoscope Reprocessor OER-Elite, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on September 1, 2020, 53 days after receiving the submission on July 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K201920 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2020
Decision Date	September 01, 2020
Days to Decision	53 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	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).