Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K082010
    Device Name
    STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    Date Cleared
    2008-12-29

    (167 days)

    Product Code
    HBF
    Regulation Number
    882.4305
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER IRELAND LTD., INSTRUMENTS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick. The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.
    Device Description
    The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.
    Ask a Question
    K Number
    K073633
    Device Name
    STRYKER ESSX MICRODEBRIDER SYSTEM
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    Date Cleared
    2008-08-26

    (244 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER IRELAND LTD., INSTRUMENTS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESSx Microdebrider System is intended for the cutting and removal of soft and osseous tissue in general ENT encompassing the areas of Sinus, Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the following: Sinus: - ethmoidectory/sphenoethmoidectomy - polypectomy - septoplasty - antrostomy - endoscopic DCR - frontal sinus drill-out - frontal sinus trephination - septal spurs removal - trans-sphenoidal procedures Nasopharyngeal/laryngeal: - adenoidectomy - laryngeal lesion debulking - laryngeal polypectomy - tracheal procedures - tonsillectomy Head & Neck: - soft tissue shaving - rhinoplasty - removal of fatty tissue in the maxillary and mandibular regions of the face
    Device Description
    The Stryker ESSx Microdebrider System is a powered instrument system consisting of a console, footswitch, handpiece, irrigation cassette, and a variety of disposable shaver accessories.
    Ask a Question

    Page 1 of 1