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

    DEKNATEL SKIN STAPLE EXTRACTOR

    K Number: K821228 · Decision May 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    373
    Review Days
    17

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    Basic Information

    Device Name
    DEKNATEL SKIN STAPLE EXTRACTOR
    K Number
    K821228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Howmedica Corp.
    Date Received
    April 27, 1982
    Decision Date
    May 14, 1982
    Product Code
    GAG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAG Stapler, Surgical

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    Other Clearances by Howmedica Corp.

    K Number Device Name
    K983528 MICRO DYNAMIC MESH
    K983404 TYPE 3 FEMORAL COMPONENTS
    K980925 DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
    K980926 DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
    K980632 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
    K980626 DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
    K983419 HOFFMANN II MIAMI POST
    K982958 ZETA MULTIZONE LOCKING NAIL SYSTEM
    K982873 ZETA MULTIZONE SCN LOCKING NAIL
    K982531 HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
    Search all 373 clearances from Howmedica Corp. →