BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZENFLOW, INC.

    Reg #: 3014211785 · FEI: 3014211785 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ZENFLOW, INC.
    Registration Number
    3014211785
    FEI Number
    3014211785
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    395 Oyster Point Blvd., Suite 501
    City
    South San Francisco
    State
    CA
    ZIP
    94080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251140
    PMA Number
    P250007

    Owner / Operator

    Firm Name
    Zenflow, Inc.
    Operator Number
    10056580
    Address
    395 Oyster Point, Suite 501
    City
    South San Francisco
    State
    CA
    Postal Code
    94080
    Country
    US
    Correspondent
    Marianne D Jacklyn

    Products

    Device Name Product Code
    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent MER
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Cystoscope And Accessories, Flexible/Rigid FAJ

    Proprietary Names

    Zenflow Spring Implant and Delivery System Zenflow Spring Implant Retrieval Device Zenflow Spring Scope Zenflow Camera Control Unit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device