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

    GLYCAR STAPLE STRIPS

    K Number: K954665 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    5
    Review Days
    127

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    Basic Information

    Device Name
    GLYCAR STAPLE STRIPS
    K Number
    K954665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glycar, Inc.
    Date Received
    October 10, 1995
    Decision Date
    February 14, 1996
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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    Other Clearances by Glycar, Inc.

    K Number Device Name
    K963967 GLYCAR PERICARDIAL PATCH
    K963368 GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE
    K963175 GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
    K942911 GLYCAR TISSUE REPAIR PATCH