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

    C2 CryoBalloon EndoGrip

    K Number: K193036 · Decision Nov 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    2
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    C2 CryoBalloon EndoGrip
    K Number
    K193036
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Medical, A Division of Pentax of America, Inc.
    Date Received
    October 31, 2019
    Decision Date
    November 22, 2019
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OCX), ordered by most recent decision date.

    AUXILIARY WATER TUBE MAJ-855

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single-Use Biopsy Valve (MAJ-1555)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ArgoCap (200.52)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoscopic Water Pump

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Water Container (MAJ-901); Water Container (MAJ-902)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Aspiration Catheter (2189)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Pentax Medical, A Division of Pentax of America, Inc.

    K Number Device Name
    K190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge