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CooperSurgical, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories10
Latest FDA decision2025-08-29
TypeNumberDevice NameCodeDateActions
510(k) K243799 Fetal PillowPWB2025-08-29 View
510(k) K250438 CooperSurgical Milex® PessariesHHW2025-04-11 View
PMA P160047 Device, thermal ablation, endometrialMNB2025-01-07 View
510(k) K223064 ALLY II Uterine Positioning System™ (UPS)LKF2022-10-28 View
510(k) K201086 Advincula Delineator Uterine ManipulatorHEW2020-05-21 View
510(k) K200038 Endosee SystemHIH2020-02-05 View
510(k) K191020 G210 InviCell Plus with SignipHy pH monitoringPUB2020-01-14 View
510(k) K191291 Wallace Dual Lumen Oocyte Recovery SystemMQE2019-06-12 View
510(k) K190639 Endosee SystemHIH2019-05-15 View
510(k) K182959 Wallace Dual Lumen Oocyte Recovery SystemMQE2019-05-10 View
510(k) K183020 Endosee SystemHIH2019-01-31 View
PMA P000032 Device, thermal ablation, endometrialMNB2018-07-11 View
510(k) K180429 Advincula Delineator Uterine ManipulatorHEW2018-03-14 View
510(k) K173731 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)MQL2018-03-02 View
510(k) K170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaHIH2017-07-13 View
510(k) K170560 SAGE Vitrification Kit and SAGE Vitrification Warming KitMQL2017-04-04 View
510(k) K151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)MPO2016-03-18 View
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