Medical Device Manufacturer · US , San Clemente , CA

Imagyn Medical, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1991

Total

Cleared

Denied

Imagyn Medical, Inc. has 19 FDA 510(k) cleared medical devices. Based in San Clemente, US.

Historical record: 19 cleared submissions from 1991 to 1997. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Imagyn Medical, Inc. Filter by specialty or product code using the sidebar.

Imagyn Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Imagyn Medical, Inc.

19 devices

1-19 of 19

Cleared Sep 23, 1997

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH

K972426 · HIH

Obstetrics & Gynecology · 88d

Cleared May 05, 1997

MICROSPAN INSEMINATION SYSTEM

K970750 · MFD

Obstetrics & Gynecology · 63d

Cleared Apr 21, 1997

IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER

K971255 · HET

Obstetrics & Gynecology · 17d

Cleared Mar 06, 1997

IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES

K965055 · HET

Obstetrics & Gynecology · 78d

Cleared Jan 31, 1997

IMAGYN FALLOPOSCOPY SYSTEM

K963580 · MKO

Obstetrics & Gynecology · 147d

Cleared Oct 15, 1996

MICROSPAN HYSTEROSCOPE

K961688 · HIH

Obstetrics & Gynecology · 167d

Cleared Jul 03, 1996

MICROSPAN HYSTEROSCOPE SHEATH

K961506 · HIH

Obstetrics & Gynecology · 75d

Cleared Oct 31, 1995

IMAGYN HYSTEROSCOPE SHEATHS

K952032 · HIH

Obstetrics & Gynecology · 183d

Cleared Sep 01, 1995

IMAGYN ENDOSCOPE

K951996 · GCJ

General & Plastic Surgery · 126d

Cleared Aug 28, 1995

IMAGYN ENDOSCOPE SHEATH

K951974 · GCJ

General & Plastic Surgery · 123d

Cleared Aug 02, 1995

IMAGYN UROSCOPE

K953201 · FAJ

Gastroenterology & Urology · 27d

Cleared Jul 24, 1995

IMAGYN HYSTEROSCOPE

K952033 · HIH

Obstetrics & Gynecology · 84d

Cleared May 15, 1995

IMAGYN INTRAUTERINE INSEMINATION DEVICE

K945131 · HDR

Obstetrics & Gynecology · 208d

Cleared Jan 26, 1995

IMAGYN MICROLAP INTRODUCER

K943810 · HET

Obstetrics & Gynecology · 174d

Cleared Jan 20, 1995

IMAGYN MICROLAP(TM) LAPAROSCOPE

K944079 · HET

Obstetrics & Gynecology · 151d

Cleared Oct 20, 1994

IMAGYN LAPAROSCOPIC INSTRUMENTS

K944129 · HET

Obstetrics & Gynecology · 57d

Cleared Aug 01, 1994

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

K940425 · MAV

Cardiovascular · 182d

Cleared Aug 18, 1993

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE

K931518 · GCJ

General & Plastic Surgery · 145d

Cleared Jun 03, 1991

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS

K911163 · FWF

General & Plastic Surgery · 80d

Imagyn Medical, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Imagyn Medical, Inc.

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