Imagyn Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHSeptember 23, 1997
K970750MICROSPAN INSEMINATION SYSTEMMay 5, 1997
K971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCERApril 21, 1997
K965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPESMarch 6, 1997
K963580IMAGYN FALLOPOSCOPY SYSTEMJanuary 31, 1997
K961688MICROSPAN HYSTEROSCOPEOctober 15, 1996
K961506MICROSPAN HYSTEROSCOPE SHEATHJuly 3, 1996
K952032IMAGYN HYSTEROSCOPE SHEATHSOctober 31, 1995
K951996IMAGYN ENDOSCOPESeptember 1, 1995
K951974IMAGYN ENDOSCOPE SHEATHAugust 28, 1995
K953201IMAGYN UROSCOPEAugust 2, 1995
K952033IMAGYN HYSTEROSCOPEJuly 24, 1995
K945131IMAGYN INTRAUTERINE INSEMINATION DEVICEMay 15, 1995
K943810IMAGYN MICROLAP INTRODUCERJanuary 26, 1995
K944079IMAGYN MICROLAP(TM) LAPAROSCOPEJanuary 20, 1995
K944129IMAGYN LAPAROSCOPIC INSTRUMENTSOctober 20, 1994
K940425IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBINGAugust 1, 1994
K931518IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCEAugust 18, 1993
K911163IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESSJune 3, 1991