BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇪 Sweden

    NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE

    K Number: K862365 · Decision Jul 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    13

    Basic Information

    Device Name
    NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
    K Number
    K862365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    SWEMED LABORATORIES, INC.
    Date Received
    June 24, 1986
    Decision Date
    July 7, 1986
    Product Code
    HIO
    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
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

    Similar 510(k) Clearances

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

    G.E. STERILE AMNIOCENTESIS TRAY

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    AMNIOTEST(TM)

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    SONO-VU US(TM), MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    MEGA AMNIOCENTESIS KIT

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology
    View all

    Other Clearances by SWEMED LABORATORIES, INC.

    K Number Device Name
    K862364 NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)