Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032109

FEI Number

3001238683

Entity Name

Gynex Corporation

City/State/Country

North Richland Hills, TX, US

Establishment Address

6631 Browning Dr, North Richland Hills, TX 76180, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GYNEX CORP. (Owner Number: 9031621)

Owner / Operator Contact Address

6631 Browning Dr, --, North Richland Hills, TX 76180, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Needle Extender tenaculum, uterine, single-use CERVICAL DILATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2007-11-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-29
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2011-03-07
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2008-02-29
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2004-09-24
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2009-12-14
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-03-13
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2011-06-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-08-18
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-08-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-10-07
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2004-09-24
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2006-08-17
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-02-03
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2006-07-18
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2017-08-15
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2023-06-26
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1997-09-17
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2007-11-07
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-11-07
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2007-11-07
ODR	Electrosurgical Patient Return Electrode	General, Plastic Surgery	Class 2	878.4400	2011-06-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-30
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2009-12-14
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-04-24
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1997-09-17
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1997-09-17
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2018-11-30
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2008-02-28
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2019-06-10
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1997-09-17
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1997-09-17
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2017-03-06
IGF	Solution, Formalin-Alcohol-Acetic Acid	Pathology	Class 1	864.4010	2023-09-18
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2023-06-19
PUA	Tenaculum, Uterine, Exempt	Obstetrics/Gynecology	Class 2	884.4530	2018-09-04
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1997-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GYNEX CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3010367859	Evident GuangZhou Co., Ltd.	Guangzhou Guangdong, CN
3013395426	NANJING JIANGNAN NOVEL OPTICS CO., LTD.	Nanjing Jiangsu, CN
3006973688	JIASHAN YINGJIE ELECTRON CO LTD	Jiashan Zhejiang, CN
9614084	MEDICAL DEVICES (PVT) LTD.	Sialkot Punjab, PK
1648557	TRANSLITE	SUGAR LAND, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032109. Last updated year: 2026. Please use registration number 3032109 when referencing this establishment in official correspondence.