Data / Medical devices / United States / Medgyn Products, Inc.
Medgyn Products, Inc.: FDA-registered device maker in Westmont, IL, United States, 44 510(k) clearances
Medgyn Products, Inc. is registered with the FDA (registration 1450908) in Westmont, IL, United States. It lists 40 device types. The FDA files 44 510(k) clearances under its listings, the newest dated November 23, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450908
- Address
- 800 Pasquinelli Dr, Westmont, IL, United States, 60559
- Owner or operator
- MEDGYN PRODUCTS, INC. (1450908)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- July 1, 1992
- Registered through
- 2026
- Brand names listed
- AL-105, Aspiration Hose, Disposable Mucous Sampler, HS Catheters Set, Inn Tec IUI Catheter, Laminaria Tent, MTA, ES100,200,300,400, Medgyn Smoke Evacuator and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 2015 | K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | MQF | Substantially Equivalent | Medgyn Products, Inc. | accessdata.fda.gov |
| March 25, 2015 | K140213 | DISPOSABLE ENDOSCOPIC CANNULA | HGH | Substantially Equivalent | Dongguan Microview Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 5, 2014 | K132313 | PESSARY | HHW | Substantially Equivalent | Eis Corporation | accessdata.fda.gov |
| August 1, 2013 | K131305 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE | IYN | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
| June 12, 2013 | K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | HEX | Substantially Equivalent | Medgyn Products, Inc. | accessdata.fda.gov |
| January 31, 2013 | K123258 | THE ADVANCE CATHETER FOR HSG AND SIS | LKF | Substantially Equivalent | Catheter Research, Inc. | accessdata.fda.gov |
| March 21, 2012 | K120154 | INTRAUTERINE INSEMINATION (IUI) CATHETER | MQF | Substantially Equivalent | Catheter Research, Inc. | accessdata.fda.gov |
| September 15, 2011 | K110766 | KOLPLUX SYSTEM | HIB | Substantially Equivalent | Kolplast CI Ltda | accessdata.fda.gov |
| June 7, 2010 | K092983 | PANPAC HSG CATHETER SET | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| November 10, 2009 | K092997 | ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 | KNG | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| November 26, 2008 | K082602 | FETAL & MATERNAL MONITOR, MODEL F6, F9 | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| November 7, 2008 | K082369 | CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 24, 2007 | K072210 | CHISON, MODEL 8300 | IYO | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
| November 22, 2005 | K052059 | IUI CATHETER, MODEL 9057 | MQF | Substantially Equivalent | Inntec, Inc. | accessdata.fda.gov |
| October 7, 2005 | K051742 | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | MQE | Substantially Equivalent | Inntec, Inc. | accessdata.fda.gov |
| May 2, 2005 | K050521 | EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S | MQF | Substantially Equivalent | Inntec, Inc. | accessdata.fda.gov |
| November 22, 2004 | K041470 | MORTON IUI CATHETERS | MQF | Substantially Equivalent | Fertility Technology Resources, Inc. | accessdata.fda.gov |
| September 2, 2004 | K040903 | CADENCE, MODELS 2001 AND 2002 | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| May 25, 2004 | K040480 | SONOTRAX ULTRASONIC POCKET DOPPLER | KNG | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| December 11, 2003 | K032835 | H/S CATHETER SET | LKF | Substantially Equivalent | Catheter Research, Inc. | accessdata.fda.gov |
| December 13, 2002 | K023017 | TUCKER EMBRYO CATHETER | MQF | Substantially Equivalent | Fertility Technology Resources, Inc. | accessdata.fda.gov |
| November 1, 2002 | K022593 | THOMAS MEDICAL ELECTRODES | HGI | Substantially Equivalent | Thomas Medical, Inc. | accessdata.fda.gov |
| October 25, 2002 | K022503 | UTERINE INJECTOR | LKF | Substantially Equivalent | Thomas Medical, Inc. | accessdata.fda.gov |
| April 17, 2002 | K020292 | UTERINE INJECTOR | LKF | Substantially Equivalent | Catheter Research, Inc. | accessdata.fda.gov |
| December 27, 2001 | K013289 | BIOTEQUE VAGINAL PESSARIES | HHW | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| June 8, 2001 | K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | BTA | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
| January 29, 2001 | K003380 | BIOTEQUE VAGINAL DILATOR | HDX | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| April 20, 1999 | K990387 | ENDOMETRIAL SAMPLER | HHK | Substantially Equivalent | U.A. Medical Products, Inc. | accessdata.fda.gov |
| February 2, 1998 | K974357 | UTERINE MANIPULATOR/INJECTOR | LKF | Substantially Equivalent | Catheter Research, Inc. | accessdata.fda.gov |
| December 19, 1997 | K973853 | KOLPLAST VAGINAL SPECULUM | HIB | Substantially Equivalent | Kolplast Comercial E Industrial Ltda | accessdata.fda.gov |
| January 26, 1995 | K945179 | BOTTLE COLLECTION SET | HGF | Substantially Equivalent | Medgyn Products, Inc. | accessdata.fda.gov |
| September 2, 1992 | K922878 | MODEL GT1ST CRYOSURGICAL INSTRUMENT | GEH | Substantially Equivalent | Gyne-Tech Instrument Corp. | accessdata.fda.gov |
| August 12, 1991 | K912422 | SURG/ASSIST MODEL SA-1 | FYD | Substantially Equivalent | Surg-Assist, Inc. | accessdata.fda.gov |
| May 21, 1991 | K911327 | CELL SWEEP | HHT | Substantially Equivalent | Reza S Mohajer, M.D. C/O Krass & Young | accessdata.fda.gov |
| June 14, 1989 | K892220 | LAMINARIA TENT | HDY | Substantially Equivalent | Berkeley Medevices | accessdata.fda.gov |
| May 6, 1988 | K880196 | LAMINARIA | HDY | Substantially Equivalent | Medgyn Products, Inc. | accessdata.fda.gov |
| March 14, 1988 | K880195 | GYNESCOPE | HEX | Substantially Equivalent | Medgyn Products, Inc. | accessdata.fda.gov |
| April 30, 1984 | K840383 | MENSTRUAL ASPIRATION KIT | HHI | Substantially Equivalent | Intl. Medical Technologies, Inc. | accessdata.fda.gov |
| April 30, 1984 | K840382 | VACUUM ASPIRATION CATHETER | HHI | Substantially Equivalent | Intl. Medical Technologies, Inc. | accessdata.fda.gov |
| March 30, 1984 | K840952 | MEDEVICE V-80 VACUUM PUMP | HHI | Substantially Equivalent | Berkeley Medevices | accessdata.fda.gov |
| June 8, 1983 | K831085 | SYNEVAC VACUUM SOURCE UNIT | BTA | Substantially Equivalent | Synemed, Inc. | accessdata.fda.gov |
| November 4, 1982 | K823006 | MEDEVICES ASPIRATION HOSE | HHK | Substantially Equivalent | Berkeley Medevices | accessdata.fda.gov |
| December 14, 1981 | K813282 | SYNEVAC VACUUM CURETTAGE SYSTEMS | HHI | Substantially Equivalent | Synemed, Inc. | accessdata.fda.gov |
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Updated November 23, 2015. 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.