COOPERSURGICAL, INC.

FDA Device Registration & Listing · Trumbull, CT, US · Registration 1216677

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1216677
FEI Number
1216677
Entity Name
COOPERSURGICAL, INC.
City/State/Country
Trumbull, CT, US
Establishment Address
95 CORPORATE DRIVE, Trumbull, CT 06611, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
COOPERSURGICAL, INC. (Owner Number: 9002384)
Owner / Operator Contact Address
95 CORPORATE DRIVE, --, Trumbull, CT 06611, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K974819
PMA Number
N/A

All Registered Proprietary Names

H/S [Elliptosphere] Catheter Holder, Needle (Multi. REDA) Hysterosalpingogram Tray TheCurve 10620010D Biopsy Medium 10620010A 10620010F 10620010 10620010M ZUMI [Uter.Manip./Inject.w/spring] UNI-SEM (TM) Wallace Oocyte Needles BlastGen 12050003 12050003D 12050003A 12050003M 12050003F 1205 Esophageal Balloon Cath.[Ackrad] LEEP Electrodes WA 1000 Console Protein Supplement LGPS-020M, LGPS-050M, LGPS-605M LGPS-020, LGPS-050, LGPS-100, LGPS-125, LGPS-250, LGPS-605 Embryo Replacement Catheter (Wallace) LifeGlobal® Global® Total® LP for Fertilization LifeGlobal® Global® Total® w/HSA LifeGlobal® Global® Total® for Fertilization w/HSA LifeGlobal® Global® Total® LP LifeGlobal® Global® Total® LP w/Hepes LifeGlobal® Global® Total® w/HEPES w/HSA KC-SIZER Apple's Vaginal Probe for Laparoscopy [900-590] CSI's Guardian Vaginal Retractor Scissors Cytobrush Plus / Plus GT SAGE Vitrification Warming Kit SAGE Vitrification Kit SAGE™ Vitrification Warming Kit ViaBL™ Super-Fast Blastocyst Warming Kit ART-8035 ART-8035, ART-8035A, ART-8035D ViaBL(TM) SUPER-FAST VITRIFICATION KIT ART-8023/ART-8023D/ART-8023M Aspirating (multi) Euromed Curette, Biopsy & CE-2000 Ophthalmic Cryosurgery Sys. Pasteur Pipets Summit PVP 10% Polyvinylpyrrolidon (PVP) 10% PVP 7% 17G Wallace Dual Lumen Integration Unit [use w/SmokeEvac.] ORIGIO Sequential Blast 83050010, 83050060, 83060010, 83060060 83050010A, 83050060A, 83060010A, 83060060A 83050010D, 83050060D, 83060010D, 83060060D 83050010M, 83050060M, 83060010M, 83060060M 83050010F, 83050060F, 83060010F, 83060060F Wallace Embryo Transfer Catheter INSORB Subcuticular Skin Stapler MityVac Super M-Style Cup, dispos. Carter-Thomason[CT] CloseSureSys. Frigi. Cryo Surg Model 5900 Vitrification Warming Kit Vitrification Kit & H/S Elliptosphere Procedure Tray HS Catheter Trays Biovac Smoke Evacuator Quantum 2000 ESU Advincular Delineator Ally UPS Dopplers,Multi., Fetal & Blood Flow WA-2000 Temperature Indicator Uterobrush LGFR-100M, LGFR-500M Global w/HEPES LGGH-050, LGGH-050, LGGH-250, LGGH-500 Washing mHTF w/HEPES & Phenol Red Media Culture System global Collect Global w/Hepes PGD Media HTF w/Hepes Global w/HEPES LGGH-050M, LGGH-050M, LGGH-250M, LGGH-500M LGFR-100, LGFR-500 Global Collect GCOL-100, GCOL-500 Global Collect GCOL-100M, GCOL-500M Instruments, Disposable (multi.) RUMI System [Mfg] RUMI II & RUMI Arch II Handles [SD] RUMI II & RUMI Arch II Handles [Mfg] Origio Gas Line Filter J-SOS-100500 - Bakri Tamponade Balloon Catheter INSORB Subcuticular Stapler- REF 2030 INSORB SEQUENTIAL FORCEPS H/Stylet, 61-0020 Sperm Select System Milex Silicone Pessaries Apple - Fischer Cone Biopsy Excisor Euro-Med Skin Punch [Skin Punch] DISPOSA-DERM 10890001A, 10905000A PVP Clinical Grade PVP Medium PVP Clinical Grade 10905000 10890001D, 10905000D PVP Medium 1089 10890001M, 10905000M PVP Medium 10890001 PVP Clinical Grade 1090 10890001F, 10905000F Custom IVF Workstation Pipelle Mystic Disposable Pump Apple-Hunt Secondary Cannula Acidified Tyrodes Solution K-SYSTEMS WORK STATIONS, TYPE, L-13W, L-13E, L-13ES, L-13ET, L-13EM K-SYSTEMS WORK STATIONS, TYPE, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E, L SignipHy Trakpod ABBI HBA SpermSlow 10944000A SpermSlow 1094 SpermSlow 10944000M 10944000D SpermSlow 10944000 10944000F INFLAT-O-BALL Aspirette Endocervical Needle J-Needle Delineator Adapter Drape LEEP Electrosurgery System & J-CRBS-184000 - Cervical Ripening Balloon with Stylet J-CRB-184000 - Cervical Ripening Balloon Sperm Preparation Medium 10690060A, 10691010A, 10695060A, 10700060A, 10701010A, 10702010A, 10705060A 10690060D, 10691010D, 10695060D, 10700060D, 10701010D, 10702010D, 10705060D 10690060F, 10691010F, 10695060F, 10700060F, 10701010F, 10702010F, 10705060F 10690060M, 10691010M, 10695060M, 10700060M, 10701010M, 10702010M, 10705060M QA Blastocyst Freeze Kit QA Embryo Freeze Kit QA Sperm Freeze Kit QA Thaw Kit MityVac w/Universal Vacuum Release [UVR] Wallach 'Star' Colposcope Endocell [Endometrial Sampler] MULTIPLE BIOPSY DEVICES PERCUTANEOUS Wallace Pessaries Miya Hook 82331 - Sani-Spec® Disposable Specula - Large 82420 - Sani-Scope® Disposable Anoscope 8311 - Galenica Vaginal Specula - Large 82341 - Sani-Spec® Disposable Speculum - Medium 8616 - Galenica Medium Vaginal Speculum 8617 - Galenica Vaginal Specula - Large 82330 - Sani-Spec® Disposable Specula - Medium 8309 - Galenica Vaginal Specula - Small 82329 - Sani-Spec® Disposable Specula - Small 8310 - Galenica Vaginal Specula - Medium 82340 - Sani-Spec® Disposable Speculum - Small 8615 - Galenica Vaginal Specula - Small Liquid Paraffin Liquid Paraffin 1010 Liquid Paraffin 10105060 10100060A, 10105060A, 10100500A Liquid Paraffin 10100060 10100060M, 10105060M, 10100500M Liquid Paraffin 10100500 10100060D, 10105060D, 10100500D 10100060F, 10105060F, 10100500F Human Serum Albumin Summit QA Medium w/HEPES QA Fertilization Medium QA Protein + Blastocyst Medium QA Protein + Fert. Medium QA Protein + Cleavage Medium QA Blastocyst Medium QA Cleavage Medium Acidified Medium w/HEPES HUI Mini-Flex[HarrisUterineInject.] C110220 - ONETRAC LXS Yankauer C110310 - ONETRAC LXS Frazier C110200 - ONETRAC LXS Yankauer C110210 - ONETRAC LXS Yankauer C110320 - ONETRAC LXS Frazier Wallace Oocyte Retrieval Needles Kronner Manipujector 83100060M, 83100125M, 83110060M, 83110125M ORIGIO Handling Medium ORIGIO Handling Medium 83110125D ORIGIO Handling Medium 8310 83100060F, 83100125F, 83110060F, 83110125F ORIGIO Handling Medium 83110060D 83100060A, 83100125A, 83110060A, 83110125A ORIGIO Handling Medium 83100060D 83100060, 83100125, 83110060, 83110125 ORIGIO Handling Medium 83100125D ORIGIO Handling Medium 8311 Wallach Loop Electrodes Inserter, Inguinal Reservoir INCA [Infant Nasal Cannulae Assy] Milex Wide-Seal Diaphragm TRAKE-fit Tracheostomy Tube Holder Euro-Med Hooks & Tenaculum Forceps, Biopsy (multi.) Phosphate Buffered Saline (PBS) Embryo Corral Dish Embryo GPS Dish 4-Welll GPS Dish Universal GPS Dish 38Special GPS Dish Mini GPS Dish MGPS-010M ?Drop GPS® Dish MGPS-010, UGPS-010, EGPS-010, EMBC-010, 4GPS-010, MI38-010, SP38-010 µDrop GPS Dish MGPS-010M, UGPS-010M, EGPS-010M, EMBC-010M, 4GPS-010M, MI38-010M, SP38-010M Summit Advincula Delineator Flexible Soft Cup Infant Heel Warmer / WarmGel Infant Heel Warmer 10300060A, 10301010A, 10305060A, 10310060A, 10311010A, 10315060A Universal IVF Medium 10300060, 10301010, 10305060, 10310060, 10311010, 10315060 10300060F, 10301010F, 10305060F, 10310060F, 10311010F, 10315060F 10300060D, 10301010D, 10305060D, 10310060D, 10311010D, 10315060D 10300060M, 10301010M, 10305060M, 10310060M, 10311010M, 10315060M Summit PIPETTES ER Peak & Embryo Biopsy Kits AMNIOTOME DISPOSABLE AMNIOTOME Potocky Needle, Disposable Injection Needle MityVac OB Vacuum Cup(s), Multi. [Reusable] Uterine Injector w/Spring [ZUI] Pap-Perfect Plastic Spatula TRANSWARMER Apple Hunt Organizer H/S Catheter [61-30## & 61-50##] Ultrafreeze TRAKEFIT TRACHEOSTOMY TUBE HOLDER N-DOSURE Vaginal-Silicone Dilators Dil-Os Dilator Cervical OS Finder INFUSET AND IRRIJET STERILE SETS Tis-U-Trap w/Metal Curette Knot Pusher 6066 - Potocky Needle® 920009 - Wallach® Endocervical Block Kit ULTRA PLUME AWAY - 6 Laparoscopic Smoke Evacuation Sys. [SeeClear & Plume-Away] PLUME AWAY - 4 J-SOSR-100500 - Cook Bakri Postpartum Balloon w rapid install components J-SOS-100500 - Bakri Tamponade Balloon Catheter LL 100 N2O Cryosurgical System & Cryo Tips REDA Hysterectomy Scissors (mult.) REDA Z-clamp Forceps (mult.) Pioneer Pumps Pap-Perfect Multi-Test Tray Kevor-Curette EmbryoGen 12040003 EmbryoGen/BlastGen 12062003 12040003M, 12062003M 12040003A, 12062003A 12040003D, 12062003D Endocervical Block Needle Sequential Cleav 83030010, 83030060, 83040010, 83040060 83030010M, 83030060M, 83040010M, 83040060M ORIGIO Sequential Cleav ORIGIO Sequential Fert Sequential Cleav w/o phenol red 8303 Sequential Cleav w/o phenol red 83030060 Sequential Cleav w/o phenol red 83030010 Sequential Cleav with phenol red 83040010 83010010F, 83010060F, 83020010F, 83020060F 83030010A, 83030060A, 83040010A, 83040060A Sequential Fert with phenol red 8302 Sequential Fert 83010010, 83010060, 83020010, 83020060 83030010D, 83030060D, 83040010D, 83040060D Sequential Fert with phenol red 83020060 Sequential Cleav with phenol red 83040060 83010010M, 83010060M, 83020010M, 83020060M 83010010D, 83010060D, 83020010D, 83020060D 83030010F, 83030060F, 83040010F, 83040060F Sequential Fert with phenol red 83020010 83010010A, 83010060A, 83020010A, 83020060A Sequential Fert w/o phenol red 83010060 Sequential Fert w/o phenol red 83010010 Sequential Cleav with phenol red 8304 Sequential Fert w/o phenol red 8301 Pioneer Pump BlastThaw BlastFreeze 10542010 10542010M 10542010F 10532010F 10542010D 10542010A RAPP Laparoscopic Instruments Nu-Tip Laparoscopic Instruments; MityVac "M" Style Vacuum Cup ZMH0850M - ZyMot Multi Sperm Separation Device ZMH3000M - ZyMot Multi Sperm Separation Device Marlow Balloon Cannulae, Family of NEO-PREP SKIN BARRIER Inseminator Pipet Curet 10840125M, 10845060M Flushing Medium w/o Heparin Flushing medium 10840125, 10845060 10840125F, 10845060F 10840125D, 10845060D 10840125A, 10845060A Scissors, Episiotomy & Parametrium [HBH & Zeppelin] Global Total for Fertilization LGTF-020, LGTF-050, LGTF-100 Global Total LGGT-030M, LGGT-060M, LGGT-100M Life Global Total for Fertilization LifeGlobal Total w/HEPES LifeGlobal Total Global Total LGGT-030, LGGT-060, LGGT-100 Global Total for Fertilization LGTF-020M, LGTF-050M, LGTF-100M Global Total w/HEPES LGTH-050M, LGTH-100M, LGTH-250M Global Total w/HEPES LGTH-050, LGTH-100, LGTH-250 IRRIJET CS-76 / CryoCare1 [Frigi.] 12284001D, 12295002D Medicult Vitrification Cooling and Warming 12284001M, 12295002M 12284001 and 12295002 Medicult Vitrification Cooling and Warming 12284001F, 12295002F 12284001A, 12295002A C Safe HTF Media FERTILIZATION MEDIA Hyaluronidase 80 U/ml PureCeption 24-Determination Bi-Layer Kit PureCeption, Lower & Upper Phase PureCeption 100% Isotonic Solution METRA PS Procedure Kit MediCult IVM System 82214010 82214010A 82214010D 82214010M QA HTF Medium w/HEPES Wallach 'Scope' Colposcope 6080 Smoke Evacuator Sys/Access. NEO-FIT AND COMFIT END Lumax TS Pro System Summit Wallace Dual Lumen 16G Apple OB/Mobius Elastic Retractor Stripper PGD Stripper Tips 67020010D, 67020060D SAGE 1-Step 67010010, 67010060 67010010D, 67010060D 67020010F, 67020060F 67010010M, 67010060M 67010010A, 67010060A 67010010F, 67010060F 67020010A, 67020060A 67020010M, 67020060M 67020010, 67020060 R G Edwards Cath for EmbryoTransfer SAGE Vitrification Kit & Warming Kit SynVitro® Hyadase 15115001 15115001F 15115001D 15115001A SynVitro® Hyadase 1511 15115001X Inserter, DMI, Multiple RECTAL DILATOR Endosee Advance Euromed Forceps (multi.) FP-010 - Fetal Pillow Global Fertilization GLOBAL Embryo Culture and Transfer LGGG-020, LGGG-050, LGGG-100, LGGF-020, LGGF-050, LGGF-100 LGGG-020M, LGGG-050M, LGGG-100M, LGGF-020M, LGGF-050M, LGGF-100M DP-M350-CHG1 - Doppler Battery Charger DP-M350 - Doppler Monitor DP-MCV01 - Doppler Monitor Cable-Verifier Summit Apple Pneumo-Matic Insufflation Needle G03014 - Doppler Long Cuff Probe DP-SDP002 - Doppler Long Cuff Probe G21363 - Doppler Probe DP-SDP001 - Doppler Probe 15135001D 15135001M SynVitro® Hyadase 1513 15135001A ORIGIO Sperm Wash 84051010 ORIGIO Gradient 100 84000060 ORIGIO Sperm Wash 84050060 84000060F, 84002060F, 84004125F, 84010060F, 84021210F, 84022010F, 84022060F, 84050060F, 84051010F, 84055060F 84000060A, 84002060A, 84004125A, 84010060A, 84021210A, 84022010A, 84022060A, 84050060A, 84051010A, 84055060A CCB Density Gradient ORIGIO® Gradient™ 90 w/o Gentamicin 84905060 (8490) ORIGIO Gradient 100 ORIGIO Gradient 90 ORIGIO Gradient 40/80 Sperm Wash ORIGIO Gradient 40 ORIGIO Gradient 80 ORIGIO Gradient 100 84004125 ORIGIO Sperm Wash 8405 ORIGIO Gradient 40/80 84021210 ORIGIO Gradient 40/80 84022060 ORIGIO Gradient 100 84002060 84000060D, 84002060D, 84004125D, 84010060D, 84021210D, 84022010D, 84022060D, 84050060D, 84051010D, 84055060D ORIGIO Sperm Wash 84055060 84000060M, 84002060M, 84004125M, 84010060M, 84021210M, 84022010M, 84022060M, 84050060M, 84051010M, 84055060M ORIGIO Gradient 40/80 84022010 ORIGIO® Gradient™ 90 w/o Gentamicin 84905060D (8490) ORIGIO Gradient 90 84010060 SelectMucus G21364 - Doppler Extension Cable DP-CAB01 - Doppler Extension Cable SelectCells Standard [SM200] & Mini [SM203] Coda Intrauterine Insemination Catheter COMFIT Endotracheal Tube Holder PICSI Dish SynVitro® Flush 15840125 15840125A SynVitro® Flush w/o Heparin 15840125 15840125F SynVitro® Flush without Heparin 15840125 15840125D EZ-Tip Singles, EZ-Tip vial of 20, EZ-Grip Water for Tissue Culture (500/1.5L) Advincula Delineator Flexible Soft Cup ORIGIO - PIPETTES Stripper TIps Sperm Select

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2008-03-12
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2010-07-28
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2008-03-17
MFD Cannula, Intrauterine Insemination Obstetrics/Gynecology Class 2 884.5250 2008-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2026-06-16
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2008-03-17
MFD Cannula, Intrauterine Insemination Obstetrics/Gynecology Class 2 884.5250 2008-03-17
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2018-06-21
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2008-03-17
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2008-04-17
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2008-03-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-14
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2018-05-01
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2002-09-11
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2010-02-01
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2008-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-15
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2010-07-28
HQA Unit, Cryotherapy, Ophthalmic Ophthalmic Class 2 886.4170 2010-03-04
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2015-06-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-11-06
HEK Monitor, Heart Sound, Fetal, Ultrasonic Obstetrics/Gynecology Class 2 884.2660 2012-11-06
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-05-22
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2008-03-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2018-05-07
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2021-05-19
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2008-03-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-03-18
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2008-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-12-05
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2008-03-12
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-18
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2008-03-18
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2015-08-26
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-07-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2008-03-18
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2001-09-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-03-18
HFE Brush, Endometrial Obstetrics/Gynecology Class 2 884.1100 2006-07-28
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1999-03-15
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2008-03-17
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2014-12-04
OQY Intrauterine Tamponade Balloon Obstetrics/Gynecology Class 2 884.4530 2025-12-05
QQS Stapler, Skin General Hospital Class 1 878.4740 2023-11-06
HTD Forceps General, Plastic Surgery Class 1 878.4800 2021-05-19
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-05-01
HDR Cap, Cervical Obstetrics/Gynecology Class 2 884.5250 2008-03-12
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2008-03-14
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2011-09-02
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 1994-01-31
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2014-12-04
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2008-08-18
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2008-03-12
DRC Trocar Cardiovascular Class 2 870.1390 2011-09-02
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2023-12-19
PUB Accessory, Assisted Reproduction, Exempt Obstetrics/Gynecology Class 2 884.6120 2020-02-25
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-07-01
POV Semen Analysis Device Hematology Class 2 864.5220 2020-01-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2008-03-13
HFC Aspirator, Endocervical Obstetrics/Gynecology Class 2 884.1050 2008-03-13
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2009-01-12
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2016-02-01
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2008-03-18
PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor Obstetrics/Gynecology Class 2 884.4260 2025-11-20
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2008-12-05
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2008-03-18
HFF Aspirator, Endometrial Obstetrics/Gynecology Class 2 884.1060 2008-03-18
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2004-03-01
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2018-05-01
KNA Instrument, Manual, Specialized Obstetric-Gynecologic Obstetrics/Gynecology Class 2 884.4530 2009-02-18
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2011-01-04
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-11-06
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2008-03-13
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2026-06-18
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2018-05-07
HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) Obstetrics/Gynecology Class 2 884.1300 2008-03-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-03-18
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2007-12-06
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-03-17
HDW Diaphragm, Contraceptive (And Accessories) Obstetrics/Gynecology Class 2 884.5350 2008-03-14
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2008-03-13
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 1999-03-15
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2022-02-10
HEP Monitor, Blood-Flow, Ultrasonic Obstetrics/Gynecology Class 2 884.2660 2012-11-06
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2012-11-06
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2018-04-26
MPO Infant Heel Warmer (Chemical Heat Pack) Physical Medicine Class 1 890.5710 2017-02-08
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
JAF Monitor, Ultrasonic, Nonfetal Radiology Class 2 892.1540 2012-11-06
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2016-01-14
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2020-02-11
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 2002-02-23
HEE Set, Anesthesia, Paracervical Obstetrics/Gynecology Class 2 884.5100 2013-01-09
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2008-03-18
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2008-03-17
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2008-03-13
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2008-03-17
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2001-12-26
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2008-12-05
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2008-03-18
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2003-05-09
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 1977-12-09
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2003-05-09
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2008-03-12
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2016-05-10
HEE Set, Anesthesia, Paracervical Obstetrics/Gynecology Class 2 884.5100 2008-03-27
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2010-03-05
OQY Intrauterine Tamponade Balloon Obstetrics/Gynecology Class 2 884.4530 2025-12-05
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2008-03-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2010-02-01
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2019-11-04
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2008-03-13
PCF Sampler, Endocervical Obstetrics/Gynecology Class 2 884.1050 2016-06-20
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
HEE Set, Anesthesia, Paracervical Obstetrics/Gynecology Class 2 884.5100 2008-03-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2019-11-04
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2007-12-05
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2008-03-13
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2025-11-21
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2008-03-17
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2003-05-09
MFD Cannula, Intrauterine Insemination Obstetrics/Gynecology Class 2 884.5250 2008-03-18
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2008-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 1999-03-15
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2008-03-12
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2008-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2026-06-16
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2014-10-20
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-03-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2008-03-18
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2008-03-17
JAY Support, Breathing Tube Anesthesiology Class 1 868.5280 2003-05-09
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2008-03-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2012-11-06
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-06-13
GAD Retractor General, Plastic Surgery Class 1 878.4800 2011-09-02
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2016-01-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2008-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2017-05-03
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2001-09-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2007-12-06
FFP Dilator, Rectal Gastroenterology, Urology Class 1 876.5450 2005-02-17
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2019-11-18
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-11-18
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1977-12-09
PWB Fetal Head Elevator Obstetrics/Gynecology Class 2 884.4350 2024-12-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2025-09-19
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2025-09-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-19
MAA Monitor, Fetal Doppler Ultrasound Obstetrics/Gynecology Class 2 884.2660 2012-11-06
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2011-09-02
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-01-09
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
HFC Aspirator, Endocervical Obstetrics/Gynecology Class 2 884.1050 2016-04-20
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2026-01-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-01-13
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2011-08-26
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2019-11-04
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2008-03-12
JAY Support, Breathing Tube Anesthesiology Class 1 868.5280 2008-03-12
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2020-01-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-01-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2025-05-21
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2020-06-11
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2016-01-14
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2016-04-21

Official Correspondent

Brian Szeremeta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOPERSURGICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9611604 LEISEGANG FEINMECHANIK-OPTIK GMBH BERLIN, DE
1627186 Lone Star Medical Products Stafford, TX, US
8010251 HBH MEDIZINTECHNIK GMBH TUTTLINGEN Baden-Wurttemberg, DE
3014755376 CooperSurgical Distribution B.V. Herten Limburg, NL
3014295858 COOPER MEDICAL, SRL La Garita Alajuela, CR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K963031 Genx Intl., Inc. GENXCATHETER 1996-10-21
K011481 Conception Technologies 10% PVP; 10% PVP IN EBSS SOLUTION 2001-07-02
K082727 Vitrolife Sweden AB FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN 2009-02-06
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 2020-01-07
K760953 Spembly Medical , Ltd. DEEP FREEZE SYSTEM (DFS-30) 1976-11-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-05 CooperSurgical, Inc. 2
Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047
Z-0029-2020 CooperSurgical, Inc. 2
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.
Z-0008-2013 Gynex Corporation 2
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Z-0034-2012 X Spine Systems Inc 1
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1216677. Last updated year: 2026. Please use registration number 1216677 when referencing this establishment in official correspondence.
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