CooperSurgical, Inc.
CooperSurgical, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2026, with 83 FDA device recalls on record.
Top product codes for CooperSurgical, Inc.
FDA recalls by CooperSurgical, Inc.
10 most recent of 83- Z-2136-2025 — Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
- Z-2135-2025 — HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
- Z-2137-2025 — Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Z-0688-2025 — Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
- Z-0690-2025 — Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
- Z-0689-2025 — Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
- Z-0687-2025 — Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
- Z-0692-2025 — Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
- Z-0691-2025 — Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
- Z-3189-2024 — Stainless Steel Sims Uterine Sound, Part Number 64-601
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by CooperSurgical, Inc.
- K261083 — Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
- K243799 — Fetal Pillow
- K250438 — CooperSurgical Milex® Pessaries
- K223064 — ALLY II Uterine Positioning System (UPS)
- K201086 — Advincula Delineator Uterine Manipulator
- K200038 — Endosee System
- K191020 — G210 InviCell Plus with SignipHy pH monitoring
- K191291 — Wallace Dual Lumen Oocyte Recovery System
- K190639 — Endosee System
- K182959 — Wallace Dual Lumen Oocyte Recovery System
- K183020 — Endosee System
- K180429 — Advincula Delineator Uterine Manipulator
- K173731 — SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
- K170660 — Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
- K170560 — SAGE Vitrification Kit and SAGE Vitrification Warming Kit
- K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
- K153092 — Ally Uterine Positioning System
- K143650 — CooperSurgical Advincula Delineator Uterine Manipulator
- K143415 — Air Bubble Based Infuser (ABBI)
- K141523 — ALLY UPS
- K140754 — COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
- K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
- K021237 — COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
- K023930 — COOPERSURGICAL OOCYTE RECOVERY NEEDLES
- K990348 — WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
- K990349 — WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
- K990350 — WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
- K990852 — COOPERSURGICAL INFRARED COAGULATOR
- K990850 — COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
- K990855 — COOPERSURGICAL INFRARED COAGULATOR FOR ENT
- K972630 — COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
- K971836 — VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
- K971838 — MICRO ELECTRODES
- K971837 — VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
- K954311 — KOH COLPOTOMIZER SYSTEM
- K951898 — VERSA-VU
- K952483 — LEEP SYSTEM 1000
- K914108 — RG27-SERIES RESECTOSCOPE AND ACCESSORIES
- K910377 — COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
- K910253 — LEEP REDIKIT
- K910254 — DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
- K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.