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510(k) Data Aggregation

    K Number
    K250598
    Device Name
    Endoform Reconstructive Template - PLGA
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2025-06-03

    (95 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.
    Device Description
    Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.
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    K Number
    K231305
    Device Name
    Endoform Dental Membrane
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2024-01-23

    (263 days)

    Product Code
    NPL, NPM
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.
    Device Description
    Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.
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    K Number
    K223373
    Device Name
    Enivo™
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2023-04-07

    (154 days)

    Product Code
    BTA, DAT
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
    Device Description
    Enivo™ is a surgical drainage system intended for the removal of surgical and bodily fluids from a closed wound. The system can be used in both home and healthcare environments. The system includes two primary components: - A vacuum device unit that includes a single-use, portable, and battery-powered vacuum device that provides continuous operation for up to 30 days and a disposable exudate reservoir. - a removable silicone drainage catheter
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    K Number
    K200502
    Device Name
    Myriad Particles
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2021-03-31

    (397 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Myriad™ Particles is indicated for use in the management of the following wounds: - · partial and full-thickness wounds - · pressure ulcers - venous ulcers . - diabetic ulcers . - chronic vascular ulcers . - . tunneled/undermined wounds - Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, . wound dehiscence) - . trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) - · draining wounds
    Device Description
    Myriad™ Particles is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
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    K Number
    K200413
    Device Name
    Symphony
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2020-07-29

    (161 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Symphony™ is indicated for use in the management of the following wounds: - · partial and full-thickness wounds - · pressure ulcers - venous ulcers - · diabetic ulcers - chronic vascular ulcers - · tunnelled / undermined wounds - · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) - draining wounds
    Device Description
    Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular collagen matrix. The 4-ply rectangular devices are available in sizes up to 200 cm².
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    K Number
    K183398
    Device Name
    Endoform Restella
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2019-04-11

    (125 days)

    Product Code
    FTM, FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
    Device Description
    Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.
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    K Number
    K181935
    Device Name
    Endoform Reconstructive Template - Non Absorbable
    Manufacturer
    Aroa Biosurgery Ltd.
    Date Cleared
    2018-12-04

    (138 days)

    Product Code
    FTL, FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform Reconstructive Template – Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Endoform Reconstructive Template – Non-Absorbable is indicated for use in the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
    Device Description
    Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with non-resorbable polypropylene (PP) suture material in a variety of sizes for use in soft tissue reconstruction. Devices up to 400 cm² are available in thicknesses from 1- through 10- ply, and larger devices up to 1000cm2 are available in 4-, 6-, and 8-ply presentations.
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    K Number
    K172318
    Device Name
    Endoform Silver Dermal Template
    Manufacturer
    Aroa Biosurgery
    Date Cleared
    2017-11-17

    (108 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform Silver Dermal Template is supplied sterile and is intended for single use in the management of the following wounds: * partial and full-thickness wounds * pressure ulcers * venous ulcers * diabetic ulcers * chronic vascular ulcers * tunnelled / undermined wounds * surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) * trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) * draining wounds
    Device Description
    Endoform Silver Dermal Template (Endoform Silver) is an advanced wound care dressing primarily composed of natural, non-reconstituted collagen retaining the native extracellular matrix associated macromolecules including fibronectin, glycosaminoglycans, laminin, and elastin. Endoform Silver is supplied as sterile intact or fenestrated sheets. Endoform Silver contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to prevent microbial colonization of the dressing is effective against a broad spectrum of microbes, including Acinetobacter baumannii, Candida parapsilosis, Candida glabrata, Candida albicans, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), coagulase-negative Staphylococci, group A (betahemolytic) Streptococci, Pseudomonas aeruginosa, Aspergillus niger, and Vancomycin Resistant Enterococci (VRE). The dressing provides sustained antimicrobial effectiveness within the dressing for up to 7 days. Endoform Silver is derived from ovine (sheep) extracellular matrix and it retains the innate biological structure of the native extracellular matrix. When rehydrated with exudate or sterile saline, Endoform Silver transforms into a soft conforming sheet, which is naturally incorporated into the wound over time.
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    K Number
    K171231
    Device Name
    Endoform Topical Matrix
    Manufacturer
    Aroa Biosurgery
    Date Cleared
    2017-06-14

    (48 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aroa Biosurgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform Topical Matrix is indicated for the management of the following wounds: - partial and full-thickness wounds - · pressure ulcers - · venous ulcers - · diabetic ulcers - chronic vascular ulcers - tunnelled / undermined wounds - · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) - · draining wounds
    Device Description
    Endoform Topical Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen designed to cover, protect, and provide a moist wound environment. The device is supplied in a variety of sizes and thicknesses which can be trimmed by the surgeon to meet the individual patient's needs.
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    K Number
    K162461
    Device Name
    Endoform Plastics and Reconstructive Matrix
    Manufacturer
    AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
    Date Cleared
    2016-12-20

    (109 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
    Device Description
    Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery. For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs. Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.
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