BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Curved Illuminated Revolver, 19ga Needle Compatible

    Reg #: 3007589150 · FEI: 3007589150 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    KATALYST SURGICAL, LLC
    Registration Number
    3007589150
    FEI Number
    3007589150
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    754 Goddard ave
    City
    Chesterfield
    State
    MO
    ZIP
    63005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140362

    Owner / Operator

    Firm Name
    Katalyst Surgical, LLC
    Operator Number
    10029103
    Address
    754 Goddard Avenue
    City
    Chesterfield
    State
    MO
    Postal Code
    63005
    Country
    US
    Correspondent
    Meryl Koch

    Products

    Device Name Product Code
    Endoilluminator MPA
    Laser, Ophthalmic HQF
    Photocoagulator And Accessories HQB

    Proprietary Names

    Curved Illuminated Revolver, 19ga Needle Compatible Steerable Revolver handpiece Straight Illuminated Revolver, 19ga Needle Compatible Revolver Fiber Flexible Curved Illuminated Revolver, 19ga Needle Compatible Curved Revolver Handpiece Flexible Curved Revolver Handpiece Straight Revolver Handpiece Zeiss Revolver Illumination Adapter Stiff One-Piece Flexible Curved Revolver Handpiece Revolver Universal Connector Stellaris Revolver Illumination Adapter DORC Revolver Illumination Adapter Constellation Revolver Illumination Adapter Short 19ga Needle Revolver Illumination Adapter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device