Medical Device Manufacturer · US , Mountain View , CA

CooperSurgical, Inc.

41 submissions · 40 cleared · Since 1991
41
Total
40
Cleared
0
Denied

CooperSurgical, Inc. — FDA 510(k) Submissions

CooperSurgical, Inc. has submitted 41 FDA 510(k) premarket notifications since 1991, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hysteroscope (and Accessories), Culdoscope (and Accessories), Cannula, Manipulator/injector, Uterine, Catheter, Assisted Reproduction, Unit, Electrosurgical, Endoscopic (with Or Without Accessories) . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
Fetal Pillow
K243799 · PWB Fetal Head Elevator · Obstetrics & Gynecology
Aug 2025 261d
CooperSurgical Milex? Pessaries
K250438 · HHW Pessary, Vaginal · Obstetrics & Gynecology
Apr 2025 56d
ALLY II Uterine Positioning System? (UPS)
K223064 · LKF Cannula,... · Obstetrics & Gynecology
Oct 2022 28d
Advincula Delineator Uterine Manipulator
K201086 · HEW Culdoscope (and Accessories) · Obstetrics & Gynecology
May 2020 28d
Endosee System
K200038 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Feb 2020 28d
G210 InviCell Plus with SignipHy pH monitoring
K191020 · PUB Accessory, Assisted... · Obstetrics & Gynecology
Jan 2020 272d
Wallace Dual Lumen Oocyte Recovery System
K191291 · MQE Needle, Assisted... · Obstetrics & Gynecology
Jun 2019 29d
Endosee System
K190639 · HIH Hysteroscope (and... · Obstetrics & Gynecology
May 2019 63d
Wallace Dual Lumen Oocyte Recovery System
K182959 · MQE Needle, Assisted... · Obstetrics & Gynecology
May 2019 197d
Endosee System
K183020 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Jan 2019 91d
Advincula Delineator Uterine Manipulator
K180429 · HEW Culdoscope (and Accessories) · Obstetrics & Gynecology
Mar 2018 26d
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
K173731 · MQL Media, Reproductive · Obstetrics & Gynecology
Mar 2018 86d
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
K170660 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Jul 2017 132d
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560 · MQL Media, Reproductive · Obstetrics & Gynecology
Apr 2017 36d
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · MPO Infant Heel Warmer... · Physical Medicine
Mar 2016 255d
Ally Uterine Positioning System
K153092 · LKF Cannula,... · Obstetrics & Gynecology
Dec 2015 56d
CooperSurgical Advincula Delineator Uterine Manipulator
K143650 · HEW Culdoscope (and Accessories) · Obstetrics & Gynecology
Jul 2015 210d
Air Bubble Based Infuser (ABBI)
K143415 · LKF Cannula,... · Obstetrics & Gynecology
Feb 2015 90d
ALLY UPS
K141523 · LKF Cannula,... · Obstetrics & Gynecology
Nov 2014 169d
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · HEX Colposcope (and... · Obstetrics & Gynecology
Oct 2014 211d
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
K063223 · HDW Diaphragm, Contraceptive... · Obstetrics & Gynecology
Jan 2008 456d
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Apr 2003 357d
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · MQE Needle, Assisted... · Obstetrics & Gynecology
Jan 2003 58d
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
K990348 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Jul 1999 171d
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
K990349 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Jul 1999 171d
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