Monarch Platform, Urology

Ureteroscope And Accessories, Flexible/rigid

Auris Health Inc

The following data is part of a premarket notification filed by Auris Health Inc with the FDA for Monarch Platform, Urology.

Pre-market Notification Details

Device IDK213334
510k NumberK213334
Device Name:Monarch Platform, Urology
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant Auris Health Inc 150 Shoreline Drive Redwood City,  CA  94065
ContactAngela Wong
CorrespondentAngela Wong
Auris Health Inc 150 Shoreline Drive Redwood City,  CA  94065
Product CodeFGB  
Subsequent Product CodeFGA
Subsequent Product CodeGCB
Subsequent Product CodeLJE
Subsequent Product CodeLJH
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-06
Decision Date2022-04-29

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