BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

    K Number: K050256 · Decision Apr 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    9
    Review Days
    82

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    Basic Information

    Device Name
    APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
    K Number
    K050256
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple Medical Corp.
    Date Received
    February 3, 2005
    Decision Date
    April 26, 2005
    Product Code
    GAD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAD Retractor

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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
    K041131 APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
    K014005 APPLE MEDICAL 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