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 IDK183020
510k NumberK183020
Device Name:Endosee System
ClassificationHysteroscope (and Accessories)
Applicant CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
ContactRoaida Johnson
CorrespondentRoaida Johnson
CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-01
Decision Date2019-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937022018 K183020 000

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