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

    SILASTIC BRAND OBSTETRICAL VACUUM CUP

    K Number: K771558 · Decision Sep 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    31
    Review Days
    36

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    Basic Information

    Device Name
    SILASTIC BRAND OBSTETRICAL VACUUM CUP
    K Number
    K771558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    August 15, 1977
    Decision Date
    September 20, 1977
    Product Code
    HDB
    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
    HDB Extractor, Vacuum, Fetal

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    Other Clearances by Dow Corning Corp. Healthcare Industries Materials

    K Number Device Name
    K853186 SILASTIC INFLATABLE BONE PLUG H.P.
    K844637 WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
    K850255 DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
    K843995 TF-II HIP PROSTHESIS
    K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
    K840357 SSA HIP PROSTHESIS
    K831479 METAL-BACKED ACETABULAR CUP
    K812864 SILASTIC VOICE PROSTHESIS
    K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
    K811679 SILASTIC TENDON PASSER H.P.
    Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →