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

    INSUFFLATOR TUBING/FILTER KIT

    K Number: K922244 · Decision Sep 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    34
    Review Days
    499

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    Basic Information

    Device Name
    INSUFFLATOR TUBING/FILTER KIT
    K Number
    K922244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Concepts, Inc.
    Date Received
    May 13, 1992
    Decision Date
    September 24, 1993
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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    K935645 FLOWGUN REUSABLE IRRIGATION PROBES
    K926242 ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE
    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
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