ALLY II Uterine Positioning System™ (UPS)

Cannula, Manipulator/injector, Uterine

CooperSurgical, Inc.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Ally Ii Uterine Positioning System™ (ups).

Pre-market Notification Details

Device IDK223064
510k NumberK223064
Device Name:ALLY II Uterine Positioning System™ (UPS)
ClassificationCannula, Manipulator/injector, Uterine
Applicant CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
ContactYin Huang
CorrespondentYin Huang
CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-30
Decision Date2022-10-28

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