Gynex Corporation
North Richland Hills, TX, US
Gynex Corporation appears in FDA device records in North Richland Hills, TX. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3032109 | 3001238683 | Gynex Corporation | 6631 Browning Dr, North Richland Hills, TX 76180 US | 2026 | and 34 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- LKFCannula, Manipulator/Injector, Uterine
- GDJClamp, Surgical, General & Plastic Surgery
- HEXColposcope (And Colpomicroscope)
- PTZColposcope (And Colpomicroscope), Exempt
- FLLContinuous Measurement Thermometer
- HTFCurette
- HHKCurette, Suction, Endometrial (And Accessories)
- HCYCurette, Uterine
- KZFDevice, Medical Examination, Ac Powered
- HDQDilator, Cervical, Fixed Size
- LRJDisinfectant, Medical Devices
- HGIElectrocautery, Gynecologic (And Accessories)
- ODRElectrosurgical Patient Return Electrode
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HFBForceps, Biopsy, Gynecological
- GENForceps, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- FHQHolder, Needle, Gastroenterologic
- HDEHook, Fibroid, Gynecological
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- IBJLight, Microscope
- KMJLubricant, Patient
- KNGMonitor, Ultrasonic, Fetal
- GDMNeedle, Aspiration And Injection, Reusable
- LNWPaper, Obstetric Ph
- EMEPunch, Biopsy, Surgical
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type
- HDLRetractor, Vaginal
- LRWScissors, General, Surgical
- JOKScissors, Medical, Disposable
- HEESet, Anesthesia, Paracervical
- IGFSolution, Formalin-Alcohol-Acetic Acid
- HHMSound, Uterine
- FXESpeculum, Non-Illuminated
- HDFSpeculum, Vaginal, Metal
- HIBSpeculum, Vaginal, Nonmetal
- KYZSyringe, Irrigating (Non Dental)
- FTYTape, Measuring, Rulers And Calipers
- HDCTenaculum, Uterine
- PUATenaculum, Uterine, Exempt
- FSMTray, Surgical, Instrument
- FCZTube, Smoke Removal, Endoscopic
- IRQUnit, Heating, Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0008-2013 | 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. | The 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. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain