BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEUWAVE MEDICAL, INC.

    Reg #: 3008769756 · FEI: 3008769756 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    NEUWAVE MEDICAL, INC.
    Registration Number
    3008769756
    FEI Number
    3008769756
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3529, 3513(Suite 100) and 3543 Anderson Street
    City
    Madison
    State
    WI
    ZIP
    53704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231738

    Owner / Operator

    Firm Name
    NeuWave Medical, Inc.
    Operator Number
    10034016
    Address
    3529 Anderson Street
    City
    Madison
    State
    WI
    Postal Code
    53704
    Country
    US
    Correspondent
    Eleanor Zhou

    Products

    Device Name Product Code
    System, Ablation, Microwave And Accessories NEY
    Table And Attachments, Operating-Room BWN
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    NEUWAVE™ Microwave Ablation System and Accessories The Arm CT Mounting Brackets NEUWAVE Certus PRXT Ablation Probes NEUWAVE PR Ablation Probes Foot Switch Accessories NEUWAVE Certus Microwave Ablation System Certus LK Ablation Probes NEUWAVE PRXT Ablation Probes Certus 140 2.45GHz Ablation System NEUWAVE Certus PR Ablation Probes NEUWAVE Microwave Ablation System Certus PRXT Ablation Probes NEUWAVE LN Ablation Probes Certus LKXT Ablation Probes NEUWAVE PRS Ablation Probes NEUWAVE Certus LK Ablation Probes NEUWAVE LKXT Ablation Probes NEUWAVE Certus LKXT Ablation Probes Certus LN Ablation Probes Certus PR Ablation Probes Dual Probe Clips NEUWAVE LK Ablation Probes Certus SR Ablation Probes NEUWAVE SR Ablation Probes NEUWAVE Microwave Ablation NEUWAVE Flex Microwave Ablation System NEUWAVE Flex Microwave Ablation Probes ABLATE-IQ NEUWAVE Microwave Ablation System with Ablation Confirmation Software Certus 140 2.45GHz Ablation System with Ablation Confirmation Software

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device