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

    MTP DISPOSABLE TROCAR VALVES

    K Number: K000337 · Decision Apr 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    10
    Review Days
    69

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    Basic Information

    Device Name
    MTP DISPOSABLE TROCAR VALVES
    K Number
    K000337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mtp Medical Technical Promotion GmbH
    Date Received
    February 3, 2000
    Decision Date
    April 12, 2000
    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 Mtp Medical Technical Promotion GmbH

    K Number Device Name
    K091178 MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
    K021811 UNIDRIVE II PLUS DISPOSABLE TUBING SET
    K020599 MTP CLEARVISION DISPOSABLE TUBING SET
    K011360 MTP LAPAROMAT DISPOSABLE TUBING SET
    K994066 MTP DISPOSABLE TROCARS
    K990912 MTP EXTRACTION BAG
    K990909 MTP UROPUMP DISPOSABLE TUBING SET
    K990911 MTP ARTHROPUMP DISPOSABLE TUBING SET
    K990910 MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS