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

    APPLE MEDICAL MOBIUS ELASTIC RETRACTOR

    K Number: K014005 · Decision Feb 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    72

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    Basic Information

    Device Name
    APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
    K Number
    K014005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple Medical Corp.
    Date Received
    December 5, 2001
    Decision Date
    February 15, 2002
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Apple Medical Corp.

    K Number Device Name
    K061651 FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
    K050256 APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
    K041131 APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
    K000026 APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
    K970788 PNEUMO-MATIC INSUFFLATION NEEDLE
    K961460 LWEET CONE BIOPSY INSTRUMENT
    K952841 THE ASSISTANT
    K941506 URETERAL ILLUMINATOR