Endosee System

Hysteroscope (and Accessories)

CooperSurgical, Inc.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Endosee System.

Pre-market Notification Details

Device IDK200038
510k NumberK200038
Device Name:Endosee System
ClassificationHysteroscope (and Accessories)
Applicant CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
ContactChristine Kupchick
CorrespondentChristine Kupchick
CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-08
Decision Date2020-02-05

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