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

    ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1

    K Number: K132340 · Decision Dec 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    20
    Applicant Total
    39
    Review Days
    144

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    Basic Information

    Device Name
    ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
    K Number
    K132340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erbe USA, Inc.
    Date Received
    July 26, 2013
    Decision Date
    December 17, 2013
    Product Code
    FEQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FEQ Pump, Air, Non-Manual, For Endoscope

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    Other Clearances by Erbe USA, Inc.

    K Number Device Name
    K221177 Erbe's Tubing/Cap Sets
    K191438 ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
    K190469 ERBEFLO 2 Disposable Tubing System
    K182444 ERBEFLO Olympus Scope Port Connector
    K162152 Erbe’s CO2 Tubing/Cap Sets
    K143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
    K151041 ERBECRYO 2 Cryosurgical Unit with accessories
    K143186 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
    K133180 ERBE ESU MODEL VIO DV WITH ACCESSORIES
    K103696 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
    Search all 39 clearances from Erbe USA, Inc. →