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Data / Medical devices / United States / Gynex Corporation

Gynex Corporation: FDA-registered device maker in North Richland Hills, TX, United States, 13 510(k) clearances

Gynex Corporation is registered with the FDA (registration 3032109) in North Richland Hills, TX, United States. It lists 44 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 28, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Gynex Corporation
FDA registration number
3032109
FEI number
3001238683
Address
6631 Browning Dr, North Richland Hills, TX, United States, 76180
Owner or operator
GYNEX CORP. (9031621)
Roles
Repackager or relabeler
First device listed
September 17, 1997
Registered through
2026
Brand names listed
CERVICAL BIOPSY FORCEPS, CERVICAL DILATOR, Colposcope, Curettes, Multiple, DEPTH AND WIDTH RULERS, DILATOR STORAGE TRAY, ENDOCERVICAL CURETTE, ENDOCERVICAL SPECULUM and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, SterileKXG1Repackager or relabeleraccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Repackager or relabeleraccessdata.fda.gov
Colposcope (And Colpomicroscope)HEX2Repackager or relabeleraccessdata.fda.gov
Colposcope (And Colpomicroscope), ExemptPTZ2Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)HHK2Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Repackager or relabeleraccessdata.fda.gov
Electrosurgical Patient Return ElectrodeODR2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Specialized Obstetric-GynecologicKNA2Repackager or relabeleraccessdata.fda.gov
Light, MicroscopeIBJ1Repackager or relabeleraccessdata.fda.gov
Lubricant, PatientKMJ1Repackager or relabeleraccessdata.fda.gov
Monitor, Ultrasonic, FetalKNG2Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Paper, Obstetric PhLNW1Repackager or relabeleraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Repackager or relabeleraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Set, Anesthesia, ParacervicalHEE2Repackager or relabeleraccessdata.fda.gov
Solution, Formalin-Alcohol-Acetic AcidIGF1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tenaculum, UterineHDC2Repackager or relabeleraccessdata.fda.gov
Tenaculum, Uterine, ExemptPUA2Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Tube, Smoke Removal, EndoscopicFCZ1Repackager or relabeleraccessdata.fda.gov
Unit, Heating, PoweredIRQ1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 28, 2018K180207Non-contact Infrared ThermometerFLLSubstantially EquivalentAlicn Medical (Shenzhen), Inc.accessdata.fda.gov
January 24, 2014K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESKNGSubstantially EquivalentShenzhen Jumper Medical Equipment Co., Ltd.accessdata.fda.gov
January 10, 2014K130087PANPAC WORD/BARTHOLIN CATHETERKNASubstantially EquivalentPanpac Medical Corporationaccessdata.fda.gov
December 4, 2009K091672DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIESGEISubstantially EquivalentShuyou Electric Medical Science Co., Ltd.accessdata.fda.gov
August 7, 2006K061306CO-1000 COLPOSCOPE, MULTIPLEHEXSubstantially EquivalentGynex Corp.accessdata.fda.gov
February 10, 2005K040780ELECTROSURGICAL PENCILSGEISubstantially EquivalentHangzhou Shuyou Medical Instrument Company, Ltd.accessdata.fda.gov
September 30, 2003K032161PHEM-ALERTLNWSubstantially EquivalentFemtek,Llc.accessdata.fda.gov
October 25, 2002K022503UTERINE INJECTORLKFSubstantially EquivalentThomas Medical, Inc.accessdata.fda.gov
August 2, 2000K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26HHKSubstantially EquivalentSims Portex , Ltd.accessdata.fda.gov
March 12, 1999K982739GYNEX ELECTRODESHGISubstantially EquivalentGynex Corp.accessdata.fda.gov
August 21, 1998K980238GYNEX EXTENDED REACH NEEDLEHEESubstantially EquivalentGynex Corp.accessdata.fda.gov
March 17, 1998K980247GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUMHDCSubstantially EquivalentGynex Corp.accessdata.fda.gov
December 1, 1986K864556AQUALUBE(TM)KMJSubstantially EquivalentParker Laboratories, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 6, 201263253Class IIITerminatedSterile, 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 fThe wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.accessdata.fda.gov

Compare with other makers

Updated November 28, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.