BioGuard EUS Air/Water And Suction Valves

Endoscope Channel Accessory

Steris Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Bioguard Eus Air/water And Suction Valves.

Pre-market Notification Details

Device IDK202104
510k NumberK202104
Device Name:BioGuard EUS Air/Water And Suction Valves
ClassificationEndoscope Channel Accessory
Applicant Steris Corporation 5976 Heisley Road Mentor,  OH  44060
ContactCarroll Martin
CorrespondentCarroll Martin
Steris Corporation 5976 Heisley Road Mentor,  OH  44060
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-29
Decision Date2021-01-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10724995197688 K202104 000

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