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510(k) Data Aggregation

    K Number
    K160705
    Device Name
    Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
    Manufacturer
    Y. JACOBS MEDICAL, INC
    Date Cleared
    2016-11-23

    (254 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Y. JACOBS MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    Y . JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of absorbable polydioxanone (PDO) suture. Y. JACOBS YOUNG'S THREAD consists of: - absorbable polydioxanone (PDO) suture - absorbable PLGA cone with each suture - disposable polycarbonate hub which has no patient contact
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    K Number
    K143413
    Device Name
    J+PRAS YOUNG'S Thread
    Manufacturer
    Y. Jacobs Medical, Inc.
    Date Cleared
    2015-09-11

    (287 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Y. Jacobs Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    Y. JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The Y. JACOBS YOUNG'S THREAD will be available in single use packages, sterile after ethylene oxide (EO) gas sterilization. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of: - absorbable polydioxanone (PDO) suture
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