MEDGYN PRODUCTS, INC.

FDA Device Registration & Listing · Westmont, IL, US · Registration 1450908

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
1450908
FEI Number
1450908
Entity Name
MEDGYN PRODUCTS, INC.
City/State/Country
Westmont, IL, US
Establishment Address
800 Pasquinelli Dr, Westmont, IL 60559, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MEDGYN PRODUCTS, INC. (Owner Number: 1450908)
Owner / Operator Contact Address
800 Pasquinelli Dr., --, Westmont, IL 60559, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Aspiration Hose Medgyn Smoke Evacuator AL-105 Inn Tec IUI Catheter HS Catheters Set Uterine Manipulator Morton IUI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBA Catheter, Balloon Type General, Plastic Surgery Class 1 878.4200 2017-03-28
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2014-10-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-11-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-11-01
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2024-05-22
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2020-08-18
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2013-06-18
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2022-11-16
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2023-09-18
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-01-03
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2012-11-01
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2012-11-01
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-12-15
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1997-08-15
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2007-12-21
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2019-02-19
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-08-18
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2023-09-18
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2023-09-18
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2016-09-12
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2017-03-30
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-08-18
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2017-03-28
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2016-09-12
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2020-07-08
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2008-08-11
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2015-05-08
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2012-11-01
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2012-11-01
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-08-18
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2014-12-08
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2007-12-21
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2019-08-21
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2023-09-18
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2012-11-01
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2012-11-01
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2012-11-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-09-11
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-09-11
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-09-11
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2015-12-02
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-08-18
HHI System, Abortion, Vacuum Obstetrics/Gynecology Class 2 884.5070 2020-12-21
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2007-12-21
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2009-12-08
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 2014-10-29
HDY Dilator, Cervical, Hygroscopic-Laminaria Obstetrics/Gynecology Class 2 884.4260 2007-12-21
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2023-09-18
HHI System, Abortion, Vacuum Obstetrics/Gynecology Class 2 884.5070 2007-12-21
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-08-18
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1992-07-01

Official Correspondent

AMAR AGADI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDGYN PRODUCTS, INC.
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
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450908. Last updated year: 2026. Please use registration number 1450908 when referencing this establishment in official correspondence.
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