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FDA 510(k)

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

K-Number: K103264 · 2011-02-23

ApplicantOlympus Medical Systems Corporation
Decision Date2011-02-23
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K103264. 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-PRO MODEL OER-PRO?

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K103264.

When did ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO receive FDA 510(k) clearance?

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO received FDA 510(k) clearance on 2011-02-23, under 510(k) number K103264.

Who is the listed applicant for ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO?

The FDA product code for ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO is FEB.

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Other records listing Olympus Medical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: FEB)

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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.

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