BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Biotex

    K Number: K180992 · Decision Jul 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    456

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    Basic Information

    Device Name
    Biotex
    K Number
    K180992
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5035
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Purgo Biologics, Inc.
    Date Received
    April 16, 2018
    Decision Date
    July 16, 2019
    Product Code
    NBY
    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
    NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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    Other Clearances by Purgo Biologics, Inc.

    K Number Device Name
    K230305 THE Graft Collagen
    K230091 THE Cover
    K222549 OpenTex
    K191737 The Graft Bone Substitute
    K173188 The Graft Natural Bone Substitute