BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROCEPT BioRobotics Corporation

    Reg #: 3027788423 · FEI: 3027788423 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    PROCEPT BioRobotics Corporation
    Registration Number
    3027788423
    FEI Number
    3027788423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    150 Baytech Drive
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251082

    Owner / Operator

    Firm Name
    PROCEPT BioRobotics Corporation
    Operator Number
    10055490
    Address
    150 Baytech Drive
    City
    San Jose
    State
    CA
    Postal Code
    95134
    Country
    US
    Correspondent
    Ankur Kaushal

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    Fluid Jet Removal System PZP
    Drape, Urological, Disposable EYY

    Proprietary Names

    HYDROS TRUS Probe HYDROS Handpiece HYDROS Robotic System AQUABEAM® Robotic System AQUABEAM Robotic System Lithotomy Drape Aquablation Essential Drape Pack, DR2500

    Establishment Types

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