BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CLARUS MEDICAL, LLC.

    Reg #: 2183911 · FEI: 1000116142 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    71
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    CLARUS MEDICAL, LLC.
    Registration Number
    2183911
    FEI Number
    1000116142
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13355 10th Ave N Ste 110
    City
    Minneapolis
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974579

    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
    Accessories, Cleaning Brushes, For Endoscope MNL
    Arthroscope HRX
    Endoscope, Neurological GWG
    Tube, Tracheal (W/Wo Connector) BTR
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Powered Laser Surgical Instrument GEX
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Lamp, Endoscope, Incandescent FTI
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Instrument, Microsurgical GZX
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Light Source, Endoscope, Xenon Arc GCT

    Proprietary Names

    Model CB2-60 Video Inspection Scope Model CD-HDMI Control Box Model C2-950 Clarus Inspection Scope Model C2-350 Clarus Inspection Scope Model CD-USB Control Box Model CB1-110HD Clarus Digital Inspection Scope, High Definition Model C1-800 Clarus Inspection Scope Model CB1-110 Video Inspection Scope Model CD-1100 Video Inspection Scope Model CB2-110 Video Inspection Scope Model CB2-200 Video Inspection Scope Model 1100-501 Spinal Introducer Set Model 1100-505 Spinal Needle Set. Clarus Peel-Away Introducer Sheath 30000-V Video Airway Endoscope 1100-500 Digital SpineScope Endoscope 30200 Tube Stop, Adult CSSA2012 ClearScope Endoscope Adaptor, CS-2000 ClearScope Endoscope Adaptor 5196-903 Adapter, Storz 5196-100 Universal Light Cable 5196-904 Adapter, Wolf/Dyonics 30201 Tube Stop, Pediatric 5196-901 Adapter, ACMI 30410 Oxygen Port Connectors 30300 Laryngoscope Handle Adapter 5196-902 Adapter, Olympus 5161-100 Light Cable, ACMI-Wolf/Dyonics, 1mm 5154-100 Light Cable, ACMI-Storz, 1mm 5163-100 Light Cable, ACMI-ACMI, 1mm 5160-100 Light Cable, ACMI-Olympus, 1mm 1100-002 SHORT Cervical LASE Set Nucleotome and Accessories 5197-201 TURBO LED Light source 3000N 3000C 710 Series Endoscopes 2120 Series Neuro Endoscopes 2120-025 NeuroPEN 2120-035 NeuroPEN 2230-521 Clarus Digital ChannelScope Endoscope, 21.6cm WL, 3mm WC, 4.5mm OD 2233-513 Clarus Digital ChannelScope Endoscope, 13cm WL, 2mm WC, 4.2mm OD 5190-500 Clarus Digital Control Module 2233-511 Clarus Digital ChannelScope Endoscope, 11cm 2100-500 Clarus Digital ClarusScope Endoscope 2230-513 Clarus Digital ChannelScope Endoscope, 13cm WL, 3mm WC, 4.5mm OD 2233-521 Clarus Digital ChannelScope Endoscope, 21.6cm WL, 2mm WC, 4.2mm OD 2120-515 Clarus Digital NeuroPEN Endoscope, 15.5cm 2120-519 Clarus Digital NeuroPEN Endoscope, 19cm 2125-515 Clarus Digital MurphyScope Endoscope, 15.5cm WL 2125-515s Digital MurphyScope Endoscope straight 2232-535 Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm OD Series 1100 Endoscopes 2233-005 Neuroendoscope 2233-002 Neuroendoscope 30003-P Pocket Scope 30000-GLMM Mercury Medical Air-Vu Stylet 30000-GLS Levitan FPS Scope 30001-10 SOS Shikani Optical Stylet, Pediatric 30000-GL SOS Shikani Greenline stylet 30000-GLMMPLUS Mercury Medical Air-Vu Plus Stylet 30000-10 SOS Shikani Optical Stylet, Adult 3240-001 Forceps 3221-002 Forceps 3241-002 Forceps 35701 Forceps 35700 Forceps 3220-002 Forceps 3240-002 Forceps 21200 Nucleotome, Probe Set, Short, 2mm 5150-002 Tubing Set 5169-100 Endoscopy Pump

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device