FDA.report

510(k) K190639

Device
Endosee System
Applicant
CooperSurgical, Inc.
510(k) number
K190639
Product code
HIH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-05-15
Date received
2019-03-13
Regulation
884.1690
Classification name
Hysteroscope (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Christine Kupchick
Address
95 Corporate Dr. Trumbull CT US 06611 06611

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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