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510(k) Data Aggregation

    K Number
    K230730
    Device Name
    Apyx
    Manufacturer
    Escala Medical
    Date Cleared
    2023-07-25

    (131 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    Escala Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
    Device Description
    The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing. The Apyx device is a single use device which is supplied sterile.
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    K Number
    K213783
    Device Name
    Apyx
    Manufacturer
    Escala Medical
    Date Cleared
    2022-04-05

    (123 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    Escala Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
    Device Description
    The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx device is a single use device which is supplied sterile.
    Ask a Question

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