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510(k) Data Aggregation

    K Number
    K060878
    Device Name
    GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
    Manufacturer
    CURAMEDICAL, BV
    Date Cleared
    2006-04-13

    (13 days)

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

    CURAMEDICAL, BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.
    Device Description
    Gelita-Spon® Absorbable Gelatin Sponge USP is a sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin with haemostatic effect suitable for the control of bleeding and as a packing material. It is able to absorb blood corresponding to about 50 times its own weight and when implanted in vivo, it is completely absorbed within approximately 3 weeks. Gelita-Spon is identical to the predicate device in components, composition, specification, manufacture and packaging. Additional testing to confirm compliance with all test criteria in the USP, specifically including certain biocompatibility tests the methodology of which are slightly different from ISO 10993, was performed following FDA guidance in order to append 'USP' to the product name.
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    K Number
    K051911
    Device Name
    GELITA-SPON
    Manufacturer
    CURAMEDICAL, BV
    Date Cleared
    2005-12-06

    (145 days)

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

    CURAMEDICAL, BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gelita-Spon® Absorbable Gelatin Sponge is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.
    Device Description
    Gelita-Spon® Absorbable Gelatin Sponge is a sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin with haemostatic effect suitable for the control of bleeding and as a packing material. It is able to absorb blood corresponding to about 50 times its own weight and when implanted in vivo, it is completely absorbed within approximately 3 weeks.
    Ask a Question

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