OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

Endoscopic Central Control Unit

THE OLYMPUS OPTICAL CO.

The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Integrated Endosurgery System Endoalpha.

Pre-market Notification Details

Device IDK981993
510k NumberK981993
Device Name:OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
ClassificationEndoscopic Central Control Unit
Applicant THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville,  NY  11747 -3157
Product CodeODA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-08
Decision Date1998-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170355837 K981993 000
04953170136597 K981993 000
04953170028410 K981993 000
04953170028335 K981993 000
04953170144929 K981993 000

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