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

    SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG

    K Number: K020882 · Decision Jul 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    38
    Same Product Code
    48
    Applicant Total
    22
    Review Days
    130

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    Basic Information

    Device Name
    SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
    K Number
    K020882
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Specialties Corp
    Date Received
    March 18, 2002
    Decision Date
    July 26, 2002
    Product Code
    LZU
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LZU Plug, Punctum

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    Other Clearances by Surgical Specialties Corp

    K Number Device Name
    K141625 POLYSYN SURGICAL SUTURE
    K141558 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    K140227 MONODERM SURGICAL SUTURE
    K080985 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    K072028 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
    K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES
    K053380 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    K052962 OPTIMIZED BARB DESIGN
    Search all 22 clearances from Surgical Specialties Corp →