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

    FLUID ASPIRATION NEEDLE

    K Number: K935293 · Decision Feb 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    23
    Review Days
    104

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    Basic Information

    Device Name
    FLUID ASPIRATION NEEDLE
    K Number
    K935293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgin Surgical Instrumentation, Inc.
    Date Received
    November 3, 1993
    Decision Date
    February 15, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Surgin Surgical Instrumentation, Inc.

    K Number Device Name
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    K011195 PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
    K994015 ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
    K980849 SURGIN KIT
    K954238 SURGIN GENISIS HANDPIECE
    K950600 VACUUM SURGE SUPRESSER
    K942945 CASSETTE SYSTEM FOR STORZ
    K942944 IRRIGATION/BIPOLAR SET
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