Medgyn Products, Inc.
Westmont, IL, US
MEDGYN PRODUCTS, INC. appears in FDA device records in Westmont, IL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Medgyn Products, Inc. between 1988 and 2015. The busiest year on record is 1988, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1995 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | MQF | Substantially Equivalent | |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | HEX | Substantially Equivalent | |
| K945179 | BOTTLE COLLECTION SET | HGF | Substantially Equivalent | |
| K880196 | LAMINARIA | HDY | Substantially Equivalent | |
| K880195 | GYNESCOPE | HEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1450908 | 1450908 | MEDGYN PRODUCTS, INC. | 800 Pasquinelli Dr, Westmont, IL 60559 US | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HGEAmniotome
- FYDApparatus, Exhaust, Surgical
- KDQBottle, Collection, Vacuum
- GEEBrush, Biopsy, General & Plastic Surgery
- LKFCannula, Manipulator/Injector, Uterine
- HGHCannula, Suction, Uterine
- MQFCatheter, Assisted Reproduction
- GBACatheter, Balloon Type
- ENWCatheter, Nasopharyngeal
- HFWClamp, Umbilical
- HEXColposcope (And Colpomicroscope)
- HHKCurette, Suction, Endometrial (And Accessories)
- HCYCurette, Uterine
- HDQDilator, Cervical, Fixed Size
- HDYDilator, Cervical, Hygroscopic-Laminaria
- HDXDilator, Vaginal
- HGIElectrocautery, Gynecologic (And Accessories)
- GDFGuide, Needle, Surgical
- KOHInstrument, Manual, General Obstetric-Gynecologic
- MDMInstrument, Manual, Surgical, General Use
- HELMonitor, Heart Rate, Fetal, Ultrasonic
- KNGMonitor, Ultrasonic, Fetal
- MQENeedle, Assisted Reproduction
- HHWPessary, Vaginal
- BTAPump, Portable, Aspiration (Manual Or Powered)
- LRYPunch, Surgical
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type
- HHMSound, Uterine
- HGFSource, Abortion Unit, Vacuum
- HHTSpatula, Cervical, Cytological
- HDFSpeculum, Vaginal, Metal
- HIBSpeculum, Vaginal, Nonmetal
- HHISystem, Abortion, Vacuum
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- ITXTransducer, Ultrasonic, Diagnostic
- BYYTube, Aspirating, Flexible, Connecting
- GAZTubing, Noninvasive
- GEHUnit, Cryosurgical, Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain