Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K172179
    Device Name
    Chitogel Endoscopic Sinus Surgery Kit
    Manufacturer
    Chitogel Ltd
    Date Cleared
    2017-10-17

    (90 days)

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

    Chitogel Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chitogel Endoscopic Sinus Surgery Kit is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery - Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.
    Device Description
    The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: - Sealed vial containing 300mg Dextran Aldehyde Powder - Sealed vial containing 10ml Sodium Phosphate Buffer Solution - Sealed vial containing 10ml Chitosan Succinaamide Solution - 12cc control syringe - Fluid dispensing connector - Two (2) mixing cannulae - Malleable cannula The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing. All components are provide sterile and are for single use only.
    Ask a Question

    Page 1 of 1