510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Imagyn Medical, Inc.

San Clemente, CA, US

Imagyn Medical, Inc. appears in FDA device records in San Clemente, CA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for Imagyn Medical, Inc. between 1991 and 1997. The busiest year on record is 1995, with 8. The most recent is 1997, with 5.

Clearances by year, as a table
510(k) clearance decisions for Imagyn Medical, Inc., by decision year
YearClearances
19911
19931
19942
19958
19962
19975
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHHIHSubstantially Equivalent
K970750MICROSPAN INSEMINATION SYSTEMMFDSubstantially Equivalent
K971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCERHETSubstantially Equivalent
K965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPESHETSubstantially Equivalent
K963580IMAGYN FALLOPOSCOPY SYSTEMMKOSubstantially Equivalent
K961688MICROSPAN HYSTEROSCOPEHIHSubstantially Equivalent
K961506MICROSPAN HYSTEROSCOPE SHEATHHIHSubstantially Equivalent
K952032IMAGYN HYSTEROSCOPE SHEATHSHIHSubstantially Equivalent
K951996IMAGYN ENDOSCOPEGCJSubstantially Equivalent
K951974IMAGYN ENDOSCOPE SHEATHGCJSubstantially Equivalent
K953201IMAGYN UROSCOPEFAJSubstantially Equivalent
K952033IMAGYN HYSTEROSCOPEHIHSubstantially Equivalent
K945131IMAGYN INTRAUTERINE INSEMINATION DEVICEHDRSubstantially Equivalent
K943810IMAGYN MICROLAP INTRODUCERHETSubstantially Equivalent
K944079IMAGYN MICROLAP(TM) LAPAROSCOPEHETSubstantially Equivalent
K944129IMAGYN LAPAROSCOPIC INSTRUMENTSHETSubstantially Equivalent
K940425IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBINGMAVSubstantially Equivalent
K931518IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCEGCJSubstantially Equivalent
K911163IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESSFWFSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

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