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

    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

    K Number: K061651 · Decision Oct 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    9
    Review Days
    129

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    Basic Information

    Device Name
    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
    K Number
    K061651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple Medical Corp.
    Date Received
    June 13, 2006
    Decision Date
    October 20, 2006
    Product Code
    HGI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGI Electrocautery, Gynecologic (And Accessories)

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    Other Clearances by Apple Medical Corp.

    K Number Device Name
    K050256 APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
    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