Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183911

FEI Number

1000116142

Entity Name

CLARUS MEDICAL, LLC.

City/State/Country

Minneapolis, MN, US

Establishment Address

13355 10th Ave N Ste 110, Minneapolis, MN 55441, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

CLARUS MEDICAL, LLC. (Owner Number: 9000372)

Owner / Operator Contact Address

13355 10th Ave. N, Ste 110, Minneapolis, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K922881

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-03-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-02-13
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2021-03-29
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2009-05-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-06-02
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	1992-07-30
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2012-12-26
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-02-13
FTI	Lamp, Endoscope, Incandescent	Gastroenterology, Urology	Class 2	876.1500	2012-12-26
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2008-02-13
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2024-02-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2008-02-13

Official Correspondent

Mark Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CLARUS MEDICAL, LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183911. Last updated year: 2026. Please use registration number 2183911 when referencing this establishment in official correspondence.