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

    REPROCESSED HOT BIOPSY FORCEPS

    K Number: K050136 · Decision Jul 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    64
    Review Days
    180

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    Basic Information

    Device Name
    REPROCESSED HOT BIOPSY FORCEPS
    K Number
    K050136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilmed, Inc.
    Date Received
    January 21, 2005
    Decision Date
    July 20, 2005
    Product Code
    NLU
    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
    NLU Forceps, Biopsy, Electric, Reprocessed

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