Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Endoscope Reprocessor OER-Elite

K-Number: K201920 · 2020-09-01

ApplicantOlympus Medical Systems Corp.
Decision Date2020-09-01
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscope Reprocessor OER-Elite is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-09-01 under approval number K201920. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscope Reprocessor OER-Elite?

Endoscope Reprocessor OER-Elite is a medical device that received FDA 510(k) clearance on 2020-09-01. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K201920.

When was Endoscope Reprocessor OER-Elite approved by the FDA?

Endoscope Reprocessor OER-Elite received FDA 510(k) clearance on 2020-09-01, under approval number K201920.

What company makes Endoscope Reprocessor OER-Elite?

Endoscope Reprocessor OER-Elite is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Endoscope Reprocessor OER-Elite?

The FDA product code for Endoscope Reprocessor OER-Elite is FEB.

Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

View all 77 devices →

Related Devices (Code: FEB)

K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. K152189EVOTECH ECRAdvanced Sterilization Products (Asp) K172677Advantage Plus Pass-ThruMedivators, Inc. K162120Scope-Assist Flushing SinkCustom Ultrasonics, Inc. K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑