FDA.report

510(k) K153092

Device
Ally Uterine Positioning System
Applicant
CooperSurgical, Inc.
510(k) number
K153092
Product code
LKF  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-21
Date received
2015-10-26
Regulation
884.4530
Classification name
Cannula, Manipulator/injector, Uterine
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
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

Legacy Summary

summary

FDA Review

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