BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    WEGO-PDO Barbed Suture

    K Number: K201139 · Decision Oct 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    8
    Review Days
    175

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    Basic Information

    Device Name
    WEGO-PDO Barbed Suture
    K Number
    K201139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foosin Medical Supplies Inc., Ltd.
    Date Received
    April 28, 2020
    Decision Date
    October 20, 2020
    Product Code
    NEW
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Foosin Medical Supplies Inc., Ltd.

    K Number Device Name
    K193209 Wego-Stainless Steel
    K183001 WEGO-PGLA RAPID
    K183004 WEGO-PGA RAPID
    K170842 WEGO-PTFE
    K142810 WEGO-PGCL Absorbable Surgical Monofilament Suture
    K130735 SYNTHETIC ABSORBABLE SUTURE
    K130737 SYNTHETIC ABSORBABLE SUTURE