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

    BIOPSY DEVICE ACCESSORY

    K Number: K951326 · Decision May 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    15
    Review Days
    53

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    Basic Information

    Device Name
    BIOPSY DEVICE ACCESSORY
    K Number
    K951326
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biopsys Medical, Inc.
    Date Received
    March 23, 1995
    Decision Date
    May 15, 1995
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Biopsys Medical, Inc.

    K Number Device Name
    K970817 MICROMARK CLIP
    K970565 MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
    K963015 SURGICAL STAPLE MARKER DEVICE (MODIFY)
    K960019 RETRACTOR ARM CLAMP
    K953962 FORCEPS
    K953880 BIOPSY NEEDLE
    K951229 MODIFIED BIOPSY NEEDLE
    K950006 SURGICAL STAPLE MARKER
    K943863 NEEDLE GUIDE
    K945573 BIOPSY DEVICE ACCESSORY
    Search all 15 clearances from Biopsys Medical, Inc. →