CooperSurgical, Inc.

FDA 510(k) & PMA Approved Devices — 37 products

Total Devices37

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K261083	Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)	MQG	2026-08-19	View
510(k)	K243799	Fetal Pillow	PWB	2025-08-29	View
510(k)	K250438	CooperSurgical Milex® Pessaries	HHW	2025-04-11	View
510(k)	K223064	ALLY II Uterine Positioning System™ (UPS)	LKF	2022-10-28	View
510(k)	K201086	Advincula Delineator Uterine Manipulator	HEW	2020-05-21	View
510(k)	K200038	Endosee System	HIH	2020-02-05	View
510(k)	K191020	G210 InviCell Plus with SignipHy pH monitoring	PUB	2020-01-14	View
510(k)	K191291	Wallace Dual Lumen Oocyte Recovery System	MQE	2019-06-12	View
510(k)	K190639	Endosee System	HIH	2019-05-15	View
510(k)	K182959	Wallace Dual Lumen Oocyte Recovery System	MQE	2019-05-10	View
510(k)	K183020	Endosee System	HIH	2019-01-31	View
510(k)	K180429	Advincula Delineator Uterine Manipulator	HEW	2018-03-14	View
510(k)	K173731	SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)	MQL	2018-03-02	View
510(k)	K170660	Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula	HIH	2017-07-13	View
510(k)	K170560	SAGE Vitrification Kit and SAGE Vitrification Warming Kit	MQL	2017-04-04	View
510(k)	K151845	Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)	MPO	2016-03-18	View
510(k)	K063223	MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS	HDW	2008-01-23	View
510(k)	K021237	COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS	HET	2003-04-10	View
510(k)	K023930	COOPERSURGICAL OOCYTE RECOVERY NEEDLES	MQE	2003-01-22	View
510(k)	K990350	WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316	MQF	1999-07-26	View