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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?
    Product Code :

    PBQ

    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
    K220420
    Device Name
    Saffron Fixation System
    Manufacturer
    Coloplast A/S
    Date Cleared
    2022-06-10

    (116 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
    Device Description
    The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.
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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?
    Product Code :

    PBQ

    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.
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    K Number
    K160569
    Device Name
    NeuGuide
    Manufacturer
    POP Medical Solutions
    Date Cleared
    2016-07-06

    (128 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
    Device Description
    The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.
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    K Number
    K130059
    Device Name
    ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
    Manufacturer
    IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
    Date Cleared
    2013-07-29

    (200 days)

    Product Code
    PBQ, OTO
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach. The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
    Device Description
    The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts: - 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling. - . Plastic Handle; connects to the Fixation Device. - . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm. The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix. The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts: - 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling. - Plastic Handle; connects to the Fixation Device. . The fasteners are introduced through a 5mm trocar in laparoscopic procedures.
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    K Number
    K120831
    Device Name
    ANCHORSURE
    Manufacturer
    NEOMEDIC INTERNATIONAL S.L.
    Date Cleared
    2012-10-12

    (207 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anchorsure is indicated for attaching suture to ligaments of the pelvic floor
    Device Description
    Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.
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    K Number
    K042603
    Device Name
    GYNECARE PROLENE FASTENER SYSTEM
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2004-12-22

    (89 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor.
    Device Description
    The GYNECARE PROLENE Fastener consists of the implantable nonabsorbable PROLENE polypropylene Fastener.
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