BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IMAGYN INTRAUTERINE INSEMINATION DEVICE

    K Number: K945131 · Decision May 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    28
    Applicant Total
    19
    Review Days
    208

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IMAGYN INTRAUTERINE INSEMINATION DEVICE
    K Number
    K945131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical, Inc.
    Date Received
    October 19, 1994
    Decision Date
    May 15, 1995
    Product Code
    HDR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HDR Cap, Cervical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HDR), ordered by most recent decision date.

    Béa Applicator (BAP-GB-01)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FERTI-LILY Conception Cup

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OVES CERVICAL CAP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COOK INSEMINATION CUP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MINISPACE(TM) IUI CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COAXIAL CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Imagyn Medical, Inc.

    K Number Device Name
    K972426 MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
    K970750 MICROSPAN INSEMINATION SYSTEM
    K971255 IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
    K965055 IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
    K963580 IMAGYN FALLOPOSCOPY SYSTEM
    K961688 MICROSPAN HYSTEROSCOPE
    K961506 MICROSPAN HYSTEROSCOPE SHEATH
    K952032 IMAGYN HYSTEROSCOPE SHEATHS
    K951996 IMAGYN ENDOSCOPE
    K951974 IMAGYN ENDOSCOPE SHEATH
    Search all 19 clearances from Imagyn Medical, Inc. →