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

    CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

    K Number: K103215 · Decision Nov 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    2
    Review Days
    14

    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
    CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
    K Number
    K103215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cianna Medical
    Date Received
    November 1, 2010
    Decision Date
    November 15, 2010
    Product Code
    JAQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    JAQ System, Applicator, Radionuclide, Remote-Controlled

    Similar 510(k) Clearances

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

    MAASTRO Rectal Applicator Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    Rectal Applicator

    FDA 510(k)
    FDA Class 2 ·Radiology

    Guided Aarhus Applicator Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    CT/ MR Tandem and Ovoid Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intracavitary/Interstitial System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Titanium Flexible Geometry FSD Applicator Set (GM11013400)

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Cianna Medical

    K Number Device Name
    K120804 CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM