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

    Saffron Fixation System

    K Number: K220420 · Decision Jun 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    71
    Review Days
    116

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    Basic Information

    Device Name
    Saffron Fixation System
    K Number
    K220420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast A/S
    Date Received
    February 14, 2022
    Decision Date
    June 10, 2022
    Product Code
    PBQ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

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