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510(k) Data Aggregation

    K Number
    K251955
    Device Name
    Onflex™ Mesh
    Manufacturer
    Davol Inc., Subsidiary of C. R. Bard, Inc.
    Date Cleared
    2025-07-24

    (29 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251557
    Device Name
    Bard® Mesh; Bard® Mesh Pre-Shaped
    Manufacturer
    Davol Inc.
    Date Cleared
    2025-06-12

    (22 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.
    Device Description
    The Bard® Mesh is a nonabsorbable, sterile mesh designed for the reinforcement of soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. The Bard® Mesh Pre-Shaped is a nonabsorbable, pre-trimmed sterile mesh designed for reinforcement of inguinal hernias. The Bard® Mesh is offered in several sizes of rectangular flat sheets and in several pre-shaped configurations, known as Bard® Mesh Pre-Shaped. Bard® Mesh product family products consist of the standard, rectangular or square sizes which can be trimmed as needed to provide surgeons with more freedom to customize the prosthesis prior to implantation. The Bard® Mesh portfolio currently ranges from 1" x 4" to 10" x 14" rectangle mesh. The Bard® Mesh is comprised of knitted polypropylene monofilaments in a square or rectangular flat sheet with selvage edges. The Bard Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration with a pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair. All clinical, biological, and technical characteristics of the Bard® Mesh and Bard® Mesh Pre-Shaped are identical except that Bard® Mesh Pre-Shaped is only indicated for inguinal hernias due to the pre-cut/pre-shaped nature of the product.
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    K Number
    K250869
    Device Name
    Parietene™ Macroporous Mesh (PPM5050 )
    Manufacturer
    Sofradim Production
    Date Cleared
    2025-04-23

    (30 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.
    Device Description
    Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach. Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile. Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm). The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair. The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation. Mesh composition: monofilament polypropylene yarn (up to 11.5 g)
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    K Number
    K250098
    Device Name
    Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
    Manufacturer
    Davol Inc.
    Date Cleared
    2025-04-09

    (85 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard® Soft Mesh is indicated for the repair of ventral, incisional, and inguinal hernias. Bard® Soft Mesh Pre-Shaped is indicated for the repair of inguinal hernias.
    Device Description
    The Bard® Soft Mesh is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with ventral, incisional, and inguinal hernias. The Bard® Soft Mesh Pre-Shaped is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with inguinal hernias. The knit construction allows the mesh to be stretched in both directions, in order to accommodate and reinforce tissue defects. The Bard® Soft Mesh is comprised of knitted polypropylene monofilaments in a rectangular flat sheet ranging from 2" x 4" to 12" x 12" with smooth radiused corners. The Bard® Soft Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair.
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    K Number
    K243315
    Device Name
    ProGrip™ Self-Gripping Polypropylene Mesh
    Manufacturer
    Sofradim Production
    Date Cleared
    2025-01-17

    (87 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProGrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists. The ProGrip™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.
    Device Description
    Progrip™ self-gripping polypropylene mesh is designed to allow extraperitoneal mesh placement for the repair of inguinal and ventral hernias. Progrip™ self-gripping polypropylene mesh is made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes. The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors. Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial box or envelope with the eIFU leaflet and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial box or envelope (single pack configuration: 1 unit per commercial box or envelope).
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    K Number
    K241250
    Device Name
    3DMax Light Mesh
    Manufacturer
    Davol Inc., Subsidiary of C.R. Bard, Inc.
    Date Cleared
    2024-06-14

    (42 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K232373
    Device Name
    Progrip™ Self-Gripping Polypropylene Mesh
    Manufacturer
    Sofradim Production
    Date Cleared
    2024-01-18

    (163 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.
    Device Description
    Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes. The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors. Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).
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    K Number
    K233402
    Device Name
    Bard 3DMax Mesh
    Manufacturer
    Davol Inc., Subsidiary of C.R. Bard, Inc.
    Date Cleared
    2023-11-01

    (28 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.
    Device Description
    The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.
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    K Number
    K232924
    Device Name
    T-Line® Hernia Mesh
    Manufacturer
    Deep Blue Medical Advances, Inc.
    Date Cleared
    2023-10-18

    (29 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).
    Device Description
    The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using well-established standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Meshare incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
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    K Number
    K230671
    Device Name
    Pitch PaSoft Tissue Reinforcement Device
    Manufacturer
    Xiros Ltd
    Date Cleared
    2023-05-31

    (82 days)

    Product Code
    FTL, OWX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    FTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. The Pitch -Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
    Device Description
    The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile, by Gamma Irradiation to an SAL of 10-6. The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.
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