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510(k) Data Aggregation

    K Number
    K070496
    Device Name
    ADVACOAT SINUS GEL AND STENT
    Manufacturer
    CARBYLAN BIOSURGERY
    Date Cleared
    2007-03-15

    (23 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARBYLAN BIOSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AdvaCoat™ Sinus Gel and Stent are indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.
    Device Description
    AdvaCoat™ Sinus Gel and Stent (AdvaCoat™) is a sterile, non-pyrogenic, viscoelastic, bioresorbable material composed of cross-linked polymers of a derivatized hyaluronan. AdvaCoat™ is produced from a non-animal, nonpathogenic source using a highly purified hyaluronan. AdvaCoat™ Sinus Gel and Stent and its break down products are biocompatible, non-immunogenic and non-toxic. AdvaCoat™ Sinus Gel and Stent are provided in two formats, a gel and a stent. The gel is delivered using a syringe and the stent is applied dry as a packing material. Due to its tissue adhesive properties, AdvaCoat™ will not migrate or be dislodged from the application site. AdvaCoat™ may be used as a space occupying dressing and/or stent to minimize bleeding. Upon application, AdvaCoat™ forms a viscous and transparent gel conforming to mucosal surfaces. The final packaged product is sterilized with E-beam radiation to a Sterility Assurance Level (SAL) of 10° and intended for single use only.
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    K Number
    K063308
    Device Name
    ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
    Manufacturer
    CARBYLAN BIOSURGERY
    Date Cleared
    2006-12-04

    (32 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARBYLAN BIOSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AdvaCoat™ Sinus Gel and Stent are indicated for use in patients undergoing nasal/sinus surqery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.
    Device Description
    AdvaCoat™ Sinus Gel and Stent (AdvaCoat™) is a sterile, non-pyrogenic, non-swelling, viscoelastic, bioresorbable material composed of cross-linked polymers of a derivatized hyaluronan. AdvaCoat™ is produced from a nonanimal, non-pathogenic source using a highly purified hyaluronan. AdvaCoat™ Sinus Gel and Stent and its break down products are biocompatible, non-immunoqenic and non-toxic. AdvaCoat™ Sinus Gel and Stent are provided in two formats, a gel and a stent. The gel is delivered using a syringe and the stent is applied dry as a packing material. Due to its tissue adhesive properties, AdvaCoat™ will not migrate or be dislodged from the application site. AdvaCoat™ may be used as a space occupying dressing and/or stent to minimize bleeding. Upon application, AdvaCoat™ forms a viscous and transparent gel conforming to mucosal surfaces. The final packaged product is sterilized with E-beam radiation to a Sterility Assurance Level (SAL) of 10th and intended for single use only.
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