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

    RIZA-RIBE NEEDLE

    K Number: K953441 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    9
    Review Days
    32

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    Basic Information

    Device Name
    RIZA-RIBE NEEDLE
    K Number
    K953441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R-Med, Inc.
    Date Received
    July 17, 1995
    Decision Date
    August 18, 1995
    Product Code
    FBK
    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
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by R-Med, Inc.

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    K950108 R-MED MINI-RETRACTOR
    K942411 R-MED DISPOSABLE PLUG
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