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

    ISLAND BIOSURGICAL BOLSTER

    K Number: K960101 · Decision Dec 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    340

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    Basic Information

    Device Name
    ISLAND BIOSURGICAL BOLSTER
    K Number
    K960101
    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
    Island Biosurgical, Inc.
    Date Received
    January 11, 1996
    Decision Date
    December 16, 1996
    Product Code
    OTN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by Island Biosurgical, Inc.

    K Number Device Name
    K982042 ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
    K973022 ISLAND BIOSURGICAL INC. BNS KIT #1 & #2