BEUDAMED
    FDA Registration Active 🇺🇸 United States

    2120-515 Clarus Digital NeuroPEN Endoscope, 15.5cm

    Reg #: 2183911 · FEI: 1000116142 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CLARUS MEDICAL, LLC.
    Registration Number
    2183911
    FEI Number
    1000116142
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13355 10th Ave N Ste 110
    City
    Minneapolis
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223615

    Owner / Operator

    Firm Name
    CLARUS MEDICAL, LLC.
    Operator Number
    9000372
    Address
    13355 10th Ave. N, Ste 110
    City
    Minneapolis
    State
    MN
    Postal Code
    55441
    Country
    US
    Correspondent
    Mark F Brown

    Products

    Device Name Product Code
    Endoscope, Neurological GWG

    Proprietary Names

    2120-515 Clarus Digital NeuroPEN Endoscope, 15.5cm 2233-513 Clarus Digital ChannelScope Endoscope, 13cm 2100-500 Clarus Digital ClarusScope Endoscope 5190-500 Clarus Digital Control Module 2120-519 Clarus Digital NeuroPEN Endoscope, 19cm 2232-535 Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm OD 2233-521 Clarus Digital ChannelScope Endoscope, 21.6cm 2233-511 Clarus Digital ChannelScope Endoscope, 11cm

    Establishment Types

    Manufacture Medical Device