HTx Disposable Hysteroscope System

Hysteroscope (and Accessories)

AcuVu Inc.

The following data is part of a premarket notification filed by Acuvu Inc. with the FDA for Htx Disposable Hysteroscope System.

Pre-market Notification Details

Device IDK211227
510k NumberK211227
Device Name:HTx Disposable Hysteroscope System
ClassificationHysteroscope (and Accessories)
Applicant AcuVu Inc. 4546 El Camino Real #211 Los Altos,  CA  94022
ContactSam Mostafavi
CorrespondentSam Mostafavi
AcuVu Inc. 4546 El Camino Real #211 Los Altos,  CA  94022
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-09-15

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