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

    Erbe's Tubing/Cap Sets

    K Number: K221177 · Decision Aug 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    39
    Review Days
    108

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    Basic Information

    Device Name
    Erbe's Tubing/Cap Sets
    K Number
    K221177
    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
    April 25, 2022
    Decision Date
    August 11, 2022
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

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    Other Clearances by Erbe USA, Inc.

    K Number Device Name
    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
    K132340 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
    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. →