BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Caprolon

    K Number: K181320 · Decision Sep 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    4
    Review Days
    123

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    Basic Information

    Device Name
    Caprolon
    K Number
    K181320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Resorba Medical GmbH
    Date Received
    May 18, 2018
    Decision Date
    September 18, 2018
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Resorba Medical GmbH

    K Number Device Name
    K143584 PGA RESORBA, PGA RESOQUICK, GLYCOLON
    K143582 MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
    K141072 SUPOLENE