Benesta Hysteroscope

Hysteroscope (and Accessories)

Caldera Medical, Inc.

The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Benesta Hysteroscope.

Pre-market Notification Details

Device IDK192822
510k NumberK192822
Device Name:Benesta Hysteroscope
ClassificationHysteroscope (and Accessories)
Applicant Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills,  CA  91301
ContactVicki Gail
CorrespondentVicki Gail
Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills,  CA  91301
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-09-09

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