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510(k) Data Aggregation

    K Number
    K023481
    Device Name
    MICROVISION SCLERAL BUCKLING COMPONENTS
    Manufacturer
    MICROVISION, INC.
    Date Cleared
    2003-01-08

    (83 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Product Code :

    HQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.
    Device Description
    The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.
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    K Number
    K983581
    Device Name
    OCU-GUARD AND OCU-GUARD SUPPLE
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-11-06

    (24 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Product Code :

    HQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.
    Device Description
    Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
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    K Number
    K980816
    Device Name
    RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    1998-09-18

    (199 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Product Code :

    HQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision
    Device Description
    Not Found
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    K Number
    K963219
    Device Name
    RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    1996-10-28

    (73 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Product Code :

    HQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K950806
    Device Name
    SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
    Manufacturer
    MIRA, INC.
    Date Cleared
    1996-06-05

    (469 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Product Code :

    HQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.
    Device Description
    Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.
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