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510(k) Data Aggregation

    K Number
    K203117
    Device Name
    TissueTak device
    Manufacturer
    Via Surgical Ltd.
    Date Cleared
    2021-01-07

    (83 days)

    Product Code
    GDW, DAT
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Via Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.
    Device Description
    The TissueTak device is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia or rotator cuff repairs. The Via Surgical TissueTak device, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the TissueTak firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh/patch to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.
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    K Number
    K181668
    Device Name
    FasTouch Absorbable Fixation System
    Manufacturer
    Via Surgical Ltd.
    Date Cleared
    2019-03-13

    (261 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Via Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FasTouch Absorbable Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
    Device Description
    The FasTouch Absorbable Fixation System is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia repair. The Via Surgical FasTouch Absorbable Fixation System, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the Fas Touch firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.
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    K Number
    K162252
    Device Name
    FasTouch Fixation System
    Manufacturer
    VIA SURGICAL LTD.
    Date Cleared
    2016-11-14

    (96 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIA SURGICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FasTouch™ Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
    Device Description
    The FasTouch™ Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate hernia mesh delivery and placement in laparoscopic or open ventral hernia repair. The FasTouch™ Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair. The Via Surgical's FasTouch™ Fixation System is designed to be inserted through a laparoscopic port sleeve. The FasTouch™ Fixation System is packaged in its unloaded state and contains a handle and a cartridge. The FasTouch™ Fixation System is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
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    K Number
    K132698
    Device Name
    FASTOUCH FIXATION SYSTEM
    Manufacturer
    VIA SURGICAL LTD.
    Date Cleared
    2014-03-14

    (197 days)

    Product Code
    GDW, REG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIA SURGICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
    Device Description
    The FasTouch Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate fixation of prosthetic material to soft tissue in laparoscopic or open surgical procedures such as ventral hernia repair. The FasTouch Fixation System is disposable, single-use system. The Via Surgical's FasTouch Fixation System is designed to be inserted through a laparoscopic port sleeve but may be used during open surgical procedures as well. The FasTouch Fixation System is packaged in its unloaded state and contains a handle and a cartridge. The FasTouch Handle is a multi-fire, sterile, single-use handle that is compatible to work with Via Surgical's FasTouch cartridges (25PS cartridge).
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