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

    INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES

    K Number: K090159 · Decision Feb 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    5
    Review Days
    15

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    Basic Information

    Device Name
    INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
    K Number
    K090159
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Incisive Surgical, Inc.
    Date Received
    January 22, 2009
    Decision Date
    February 6, 2009
    Product Code
    GDW
    Advisory Committee
    General, Plastic Surgery
    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
    GDW Staple, Implantable

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    Other Clearances by Incisive Surgical, Inc.

    K Number Device Name
    K120373 INSORB ABSORBALBE STAPLE
    K061784 INSORB ABSORBABLE STAPLE, MODEL 1020
    K033602 INSORB ABSORBABLE STAPLE, MODEL SP-B20
    K024117 INSORB ABSORBABLE STAPLES, MODEL SP-B20