Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Hysteroscope (and Accessories)

Meditrina, Inc.

The following data is part of a premarket notification filed by Meditrina, Inc. with the FDA for Aveta System, Aveta Disposable Hysteroscope (pearl/opal/coral), Aveta Disposable Cystoscope (coral).

Pre-market Notification Details

Device IDK213171
510k NumberK213171
Device Name:Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
ClassificationHysteroscope (and Accessories)
Applicant Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose,  CA  95129
ContactCsaba Truckai
CorrespondentCsaba Truckai
Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose,  CA  95129
Product CodeHIH  
Subsequent Product CodeFAJ
Subsequent Product CodeHIG
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-28
Decision Date2022-05-26

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