BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Zip 4 Skin Closure Device

    K Number: K170003 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    Zip 4 Skin Closure Device
    K Number
    K170003
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zipline Medical, Inc.
    Date Received
    January 3, 2017
    Decision Date
    August 18, 2017
    Product Code
    PYO
    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
    PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use