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

    VERRES NEEDLE

    K Number: K932281 · Decision Aug 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    10
    Review Days
    86

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    Basic Information

    Device Name
    VERRES NEEDLE
    K Number
    K932281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgeon Surgical Instrumentation, Inc.
    Date Received
    May 12, 1993
    Decision Date
    August 6, 1993
    Product Code
    GCT
    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
    GCT Light Source, Endoscope, Xenon Arc

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    K880543 UNI-PORT
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    K861203 MULTI-SPIKE
    K852229 STERILE EYE PACKS OR TRAYS
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