BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Skinny Steerable Laser Probe, Iridex Connector

    Reg #: 3007589150 · FEI: 3007589150 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    75
    Establishment Types
    4
    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
    K121187

    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

    Skinny Steerable Laser Probe, Iridex Connector Curved Illuminated Laser Probe, Nidek Connector, 19ga Needle Compatible Skinny Steerable Laser Probe, Quantel Connector Flexible Curved Laser Probe, Alcon Connector Straight Laser Probe, Alcon Connector Straight Laser Probe, Nidek Connector Flexible Curved Laser Probe, Quantel Connector Curved laser Probe, DORC Connector Skinny Steerable Laser Probe, Nidek Connector Flexible Curved laser Probe, DORC Connector Curved Laser Probe, Iridex Connector Flexible Curved Illuminated Laser Probe, Nidek Connector, 19ga Needle Compatible Straight Laser Probe, Iridex Connector Flexible Curved Laser Probe, Iridex Connector Straight Illuminated Laser Probe, Alcon Connector, 19ga Needle Compatible Steerable Laser Probe, Alcon Connector Curved Laser Probe, Alcon Connector Curved Illuminated Laser Probe, Quantel Connector, 19ga Needle Compatible Curved Illuminated Laser Probe, Alcon Connector, 19ga Needle Compatible Curved Laser Probe, Nidek Connector Steerable Laser Probe, Iridex Connector Steerable Laser Probe, Nidek Connector Straight Illuminated Laser Probe, Nidek Connector, 19ga Needle Compatible Flexible Curved Illuminated Laser Probe, Quantel Connector, 19ga Needle Compatible Steerable Laser Probe, Quantel Connector Straight Illuminated Laser Probe, Iridex Connector, 19ga Needle Compatible Curved Laser Probe, Quantel Connector Straight Illuminated laser Probe, DORC Connector, 19ga Needle Compatible Curved Illuminated laser Probe, DORC Connector, 19ga Needle Compatible Flexible Curved Laser Probe, Nidek Connector Straight Laser Probe, Quantel Connector Flexible Curved Illuminated Laser Probe, Alcon Connector, 19ga Needle Compatible Flexible Curved Illuminated Laser Probe, Iridex Connector, 19ga Needle Compatible Curved Illuminated Laser Probe, Iridex Connector, 19ga Needle Compatible Straight laser Probe, DORC Connector Steerable laser Probe, DORC Connector Skinny Steerable Laser Probe, Alcon Connector Skinny Steerable laser Probe, DORC Connector Flexible Curved Illuminated laser Probe, DORC Connector, 19ga Needle Compatible Straight Illuminated Laser Probe, Quantel Connector, 19ga Needle Compatible Illuminated Inverted MultiFlex Laser Probe, Iridex Connector Focal/Standard Light Pipe, Short 19ga Needle Connector Stiff Illuminated MultiFlex Laser Probe, Iridex Connector MultiFlex Laser Probe, Dorc Connector Stiff Focal/Standard Light Pipe, 19ga Needle Connector Stiff Dispersion Widefield Light Pipe, 19ga Needle Connector Illuminated Extendable MultiFlex Laser Probe, Iridex Connector Stiff Illuminated Inverted MultiFlex Laser Probe, Iridex Connector Stiff Illuminated Extendable MultiFlex Laser Probe, Iridex Connector Shielded Light Pipe, 19ga Needle Connector Stiff Focal/Standard Light Pipe, Short 19ga Needle Connector MultiFlex Inverted Steerable Laser Probe, Iridex Connector Midfield Light Pipe, 19ga Needle Connector Focal/Standard Light Pipe, 19ga Needle Connector Dispersion Widefield Light Pipe, 19ga Needle Connector Dispersion Widefield Light Pipe, Short 19ga Needle Connector MultiFlex Steerable Laser Probe, Iridex Connector Extendable MultiFlex Laser Probe, Dorc Connector MultiFlex Extendable Inverted Steerable Laser Probe, Iridex Connector Stiff Illuminated Inverted Extendable MultiFlex Laser Probe, Iridex Connector MultiFlex Extendable Steerable Laser Probe, Iridex Connector Illuminated MultiFlex Laser Probe, Iridex Connector Shielded Light Pipe, Short 19ga Needle Connector Awh Brilliant Chandelier, Short 19ga Needle Connector MultiFlex Inverted Extendable Laser Probe, Dorc Connector Stiff Extendable MultiFlex Laser Probe, Iridex Connector Stiff Dispersion Widefield Light Pipe, Short 19ga Needle Connector Illuminated Inverted Extendable MultiFlex Laser Probe, Iridex Connector Widefield Light Pipe, Short 19ga Needle Connector Widefield Light Pipe, 19ga Needle Connector Midfield Light Pipe, Short 19ga Needle Connector Stiff Inverted MultiFlex Laser Probe, Iridex Connector Awh Brilliant Chandelier, 19ga Needle Connector Stiff MultiFlex Laser Probe, Iridex Connector Stiff Inverted Extendable MultiFlex Laser Probe, Iridex Connector

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device