BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Microwave Ablation System (BD-GT)

    K Number: K232240 · Decision Nov 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    108

    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
    Microwave Ablation System (BD-GT)
    K Number
    K232240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Betters(Suzhou) Medical Co., Ltd.
    Date Received
    July 28, 2023
    Decision Date
    November 13, 2023
    Product Code
    NEY
    Advisory Committee
    General, Plastic Surgery
    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
    NEY System, Ablation, Microwave And Accessories

    Similar 510(k) Clearances

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

    Microwave Ablation Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    swiftPro System (SWF-SPS); Swift System (SWF-SYS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Microwave Ablation Generator (KY-2000A, KY-2100A)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Microwave Ablation Antennas

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Betters(Suzhou) Medical Co., Ltd.

    K Number Device Name
    K232241 Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)