BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSTYLLA, INC.

    Reg #: 3017208642 · FEI: 3017208642 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INSTYLLA, INC.
    Registration Number
    3017208642
    FEI Number
    3017208642
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    201 Burlington Rd, North Building
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K253769
    PMA Number
    P250003

    Owner / Operator

    Firm Name
    Instylla, Inc.
    Operator Number
    10077890
    Address
    201 Burlington Rd, North Building
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Amita Shah

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Embolization Agent, Vascular QVG
    Catheter, Continuous Flush KRA

    Proprietary Names

    Instylla Delivery Kit 1mL:1mL Embrace Hydrogel Embolic System Instylla Microcatheter Instylla Microcatheter 1.2F Instylla Delivery Kit

    Establishment Types

    Manufacture Medical Device