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510(k) Data Aggregation

    K Number
    K120025
    Device Name
    SURGIMESH XB - SKIRTED
    Manufacturer
    ASPIDE MEDICAL
    Date Cleared
    2012-06-26

    (175 days)

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

    ASPIDE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair. The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera
    Device Description
    The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs. More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).
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    K Number
    K092233
    Device Name
    SURGIMESH XD
    Manufacturer
    ASPIDE MEDICAL
    Date Cleared
    2010-06-25

    (337 days)

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

    ASPIDE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGIMESH®XD mesh is recommended for reinforcement of hernia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery.
    Device Description
    The SURGIMESH®XD consists of non-absorbable synthetic mesh, made of polypropylene. The SURGIMESH®XD has a 3D shape to fit the inguinal anatomy. In addition, two translucent windows are incorporated into the SURGIMESH®XD implant to allow proper positioning of the implant. The two windows allow the surgeon to place the implant in the correct anatomical location using the Cooper's ligament and the spermatic cord as anatomical guides in repairing a hernia defect. SURGIMESH®XD mesh is supplied sterile.
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    K Number
    K072974
    Device Name
    SURGIMESH XB
    Manufacturer
    ASPIDE MEDICAL
    Date Cleared
    2008-08-18

    (301 days)

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

    ASPIDE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair. The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
    Device Description
    The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.
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    K Number
    K061445
    Device Name
    SURGIMESH WN
    Manufacturer
    ASPIDE MEDICAL
    Date Cleared
    2007-02-01

    (253 days)

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

    ASPIDE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.
    Device Description
    The SURGIMESH®WN consists of non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene. SURGIMESH®WN mesh is supplied sterile and is available in rectangular and anatomic forms in order to meet the individual patient's surgical needs.
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