BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gynex Corporation

    Reg #: 3032109 · FEI: 3001238683 · Expires 2026
    View on FDA
    Products
    44
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    44

    Registration Details

    Registration Name
    Gynex Corporation
    Registration Number
    3032109
    FEI Number
    3001238683
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6631 Browning Dr
    City
    North Richland Hills
    State
    TX
    ZIP
    76180
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040780

    Owner / Operator

    Firm Name
    GYNEX CORP.
    Operator Number
    9031621
    Address
    6631 Browning Dr, --
    City
    North Richland Hills
    State
    TX
    Postal Code
    76180
    Country
    US

    Products

    Device Name Product Code
    Light, Microscope IBJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
    Curette, Suction, Endometrial (And Accessories) HHK
    Punch, Biopsy, Surgical EME
    Holder, Needle, Gastroenterologic FHQ
    Applicator, Absorbent Tipped, Sterile KXG
    Paper, Obstetric Ph LNW
    Tray, Surgical, Instrument FSM
    Scissors, General, Surgical LRW
    Continuous Measurement Thermometer FLL
    Tape, Measuring, Rulers And Calipers FTY
    Colposcope (And Colpomicroscope) HEX
    Forceps, General & Plastic Surgery GEN
    Tube, Smoke Removal, Endoscopic FCZ
    Scissors, Medical, Disposable JOK
    Instrument, Manual, Specialized Obstetric-Gynecologic KNA
    Retractor, Vaginal HDL
    Electrocautery, Gynecologic (And Accessories) HGI
    Clamp, Surgical, General & Plastic Surgery GDJ
    Disinfectant, Medical Devices LRJ
    Electrosurgical Patient Return Electrode ODR
    Lubricant, Patient KMJ
    Guide, Needle, Surgical GDF
    Curette, Uterine HCY
    Speculum, Vaginal, Metal HDF
    Colposcope (And Colpomicroscope), Exempt PTZ
    Syringe, Irrigating (Non Dental) KYZ
    Monitor, Ultrasonic, Fetal KNG
    Sound, Uterine HHM
    Forceps, Biopsy, Gynecological HFB
    Device, Medical Examination, Ac Powered KZF
    Solution, Formalin-Alcohol-Acetic Acid IGF
    Needle, Aspiration And Injection, Reusable GDM
    Tenaculum, Uterine, Exempt PUA
    Dilator, Cervical, Fixed Size HDQ
    Speculum, Vaginal, Nonmetal HIB
    Cannula, Manipulator/Injector, Uterine LKF
    Curette HTF
    Tenaculum, Uterine HDC
    Hook, Fibroid, Gynecological HDE
    Speculum, Non-Illuminated FXE
    Set, Anesthesia, Paracervical HEE
    Unit, Heating, Powered IRQ

    Proprietary Names

    Gynex Microscope Electrosurgical Handpiece Remover, Intrauterine Device, Contraceptive, Hook-type Suresample KEYES SKIN PUNCH Needle Holders Swab PHEM-ALERT DILATOR STORAGE TRAY GYNEX OR HYSTERECTOMY SCISSORS TouchGuard Infrared Thermometer DEPTH AND WIDTH RULERS GYNEX COLPOSCOPE (MULTIPLE) GRASPER SMOKE EVACUATION TUBE I.U.D. String Scissors, Single-Use Word Bartholin Catheter LATERAL VAGINAL RETRACTOR Gynex Electrodes Gynex Clamps (Multiple) Gynex Cleaners (Multiple) Electrosurgical Dispersive Pad Lubricating Gel Needle Extender Curettes, Multiple VAGINAL SPECULUM Colposcope Gynex Syringe Gynex Ultrasonic Fetal Doppler UTERINE SOUND CERVICAL BIOPSY FORCEPS Gynex Medical Exam Light Gynex Acetic Acid tenaculum, uterine, single-use CERVICAL DILATOR single-use speculum Uterine Manipulator ENDOCERVICAL CURETTE Gynex Tenaculum (Multiple) Hook, Fibroid, Gynecological ENDOCERVICAL SPECULUM Extended Reach Needle Thermasonic Gel Warmer

    Establishment Types

    Repack or Relabel Medical Device