BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ALEXIS WOUND RETRACTOR

    K Number: K031889 · Decision Sep 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    34
    Review Days
    96

    Basic Information

    Device Name
    ALEXIS WOUND RETRACTOR
    K Number
    K031889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    APPLIED MEDICAL RESOURCES CORP.
    Date Received
    June 18, 2003
    Decision Date
    September 22, 2003
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical

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    Other Clearances by APPLIED MEDICAL RESOURCES CORP.

    K Number Device Name
    K132300 EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
    K133393 GELPOINT PATH TRANSANAL ACCESS PLATFORM
    K113268 ALEXIS O WOUND PROTECTOR/RETRACTOR
    K110792 GELPOINT PATH
    K103282 LAPAROSCOPIC DISSECTOR
    K100120 ALEXIS ORTHOPAEDIC WOUND RETRACTOR
    K093296 ALEXIS LAPAROSCOPIC SYSTEM
    K090275 GELPORT SINGLE INCISION ACCESS SYSTEM
    K083638 FIXATION TROCARS
    K072674 KII TROCAR SYSTEM
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