FDA.report

510(k) K170660

Device
Endosee Hysteroscope With Disposable Diagnostic (Dx) Cannula
Applicant
CooperSurgical, Inc.
510(k) number
K170660
Product code
HIH  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-13
Date received
2017-03-03
Regulation
884.1690
Classification name
Hysteroscope (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Roaida Johnson
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

Related GUDID Devices

Primary DIBrandCompanyPublished
60888937022485Endosee Cystoscopy KitCoopersurgical, Inc.2018-11-09
20888937022463Endosee Cystoscopy CannulaCoopersurgical, Inc.2018-11-09
00888937022452Endosee Coopersurgical, Inc.2018-11-09

Legacy Summary

summary

FDA Review

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