Advincula Delineator Uterine Manipulator

Culdoscope (and Accessories)

CooperSurgical, Inc.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Advincula Delineator Uterine Manipulator.

Pre-market Notification Details

Device IDK201086
510k NumberK201086
Device Name:Advincula Delineator Uterine Manipulator
ClassificationCuldoscope (and Accessories)
Applicant CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
ContactKyle Hooper
CorrespondentKyle Hooper
CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
Product CodeHEW  
CFR Regulation Number884.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-23
Decision Date2020-05-21

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