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

    FLOWGUN ELECTROCAUTERY PROBE HANDLE

    K Number: K935970 · Decision May 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    34
    Review Days
    154

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    Basic Information

    Device Name
    FLOWGUN ELECTROCAUTERY PROBE HANDLE
    K Number
    K935970
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Concepts, Inc.
    Date Received
    December 13, 1993
    Decision Date
    May 16, 1994
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by O.R. Concepts, Inc.

    K Number Device Name
    K941337 FLOWGUN ELECTROCAUTERY PROBES
    K935971 FLOWGUN ELECTROCAUTERY PROBES
    K935645 FLOWGUN REUSABLE IRRIGATION PROBES
    K926242 ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE
    K922244 INSUFFLATOR TUBING/FILTER KIT
    K922197 INSUFFLATOR TUBING KIT
    K932449 DR. FOG
    K925147 ORC 10.0MM SUCTION PROBE
    K925024 ORC TAPPERED IRRIGATING PROBE
    K923908 # 9455 AND #9457 POOLE TIP SUCTION PROBE
    Search all 34 clearances from O.R. Concepts, Inc. →