Cleared Traditional

ENDOSCOPE REPROCESSOR OER-Elite

K190969 · Olympus Medical Systems Corp. · General Hospital

Jul 2019

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K190969 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 July 9, 2019, 88 days after receiving the submission on April 12, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K190969 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2019
Decision Date	July 09, 2019
Days to Decision	88 days
Submission Type	Traditional
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).