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510(k) Data Aggregation

    K Number
    K083783
    Device Name
    VF LIQUIGEL
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2009-09-11

    (266 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
    Device Description
    Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.
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    K Number
    K080956
    Device Name
    MODIFICATION TO VF GEL PLUS
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2008-04-25

    (22 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
    Device Description
    Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.
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    K Number
    K071663
    Device Name
    VF GEL PLUS
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2008-02-15

    (242 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VF Gel Plus is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
    Device Description
    Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principal durable component is synthetic calcium hydroxylapatite. The semi-solid nature is created by suspending the calcium hydroxylapatite particles in a high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the carbomer (NF). The calcium hydroxylapatite particles are 25 to 45 microns in size while being smooth but irregular in shape and are present in the product at 30% by volume.
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    K Number
    K060248
    Device Name
    ULTRATINE TRANSBLEPH
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2006-06-12

    (132 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTRATINE TransBleph™ is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.
    Device Description
    The ULTRATINE TransBleph™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.
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    K Number
    K060249
    Device Name
    ULTRATINE FOREHEAD
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2006-06-12

    (132 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.
    Device Description
    The ULTRATINE Forehead™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.
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    K Number
    K060828
    Device Name
    MODIFICATION TO ENDOTINE RIBBON
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2006-04-19

    (23 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
    Device Description
    The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
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    K Number
    K051415
    Device Name
    ENDOTINE RIBBON
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2005-06-23

    (22 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
    Device Description
    The ENDOTINE Ribbon™ consists of an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.
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    K Number
    K050611
    Device Name
    ENDOTINE RIBBON
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2005-04-06

    (28 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
    Device Description
    The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
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    K Number
    K042796
    Device Name
    ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2004-11-05

    (29 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.
    Device Description
    The ENDOTINE TransBleph™ 3.0/3.5 Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.
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    K Number
    K041835
    Device Name
    ENDOTINE MIDFACE B 4.5 DEVICE
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2004-09-28

    (83 days)

    Product Code
    HWC, GAN
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAPT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOTINE Midface™ B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.
    Device Description
    The ENDOTINE Midface™-ST 4.5 consists of two components: (1) a fixation platform with anchoring leash, and (2) a screw anchor. This device is supplied sterile for single use only. The ENDOTINE Midface™ B Instrument Kit is packaged separately from the implant device and is provided to the user non-sterile. The kit is comprised of the following tools that aid in the deployment and anchoring of the implant device: - Sterilization tray (lid, base and mat) to house the instruments for transport and . sterilization - Drill bit for creating a hole in the infra-orbital rim . - Tapping tool to create the threads in the drilled hole to conform to the anchor . screw - . Insertion tool to grasp and deploy the anchor screw - Clipper tool to remove the screw flange and excess leash length .
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