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

    BIP BIOPSY NEEDLE MODIFICATION

    K Number: K934370 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    7
    Review Days
    181

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    Basic Information

    Device Name
    BIP BIOPSY NEEDLE MODIFICATION
    K Number
    K934370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bip USA, Inc.
    Date Received
    September 7, 1993
    Decision Date
    March 7, 1994
    Product Code
    FCG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCG Biopsy Needle

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    Other Clearances by Bip USA, Inc.

    K Number Device Name
    K024089 VACUFLASH BIOPSY SYSTEM
    K934371 BIP MULTI MODIFICATION
    K935457 LOCALIZATION WIRE OR MARKER - SURGICAL
    K925870 SPACER
    K925875 HORIZONTAL NEEDLE GUIDE ATTACHMENT
    K925874 BREAST STABILIZER