Data / Medical devices / United States / Clarus Medical, LLC.

Clarus Medical, LLC.: FDA-registered device maker in Minneapolis, MN, United States, 14 510(k) clearances

Name: Clarus Medical, LLC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Clarus Medical, LLC. is registered with the FDA (registration 2183911) in Minneapolis, MN, United States. It lists 12 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 25, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Clarus Medical, LLC.

FDA registration number: 2183911
FEI number: 1000116142
Address: 13355 10th Ave N Ste 110, Minneapolis, MN, United States, 55441
Owner or operator: CLARUS MEDICAL, LLC. (9000372)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: July 30, 1992
Registered through: 2026
Brand names listed: 1100-002 SHORT Cervical LASE Set, 1100-500 Digital SpineScope Endoscope, 2100-500 Clarus Digital ClarusScope Endoscope, 2120 Series Neuro Endoscopes, 2120-025 NeuroPEN, 2120-035 NeuroPEN, 2120-515 Clarus Digital NeuroPEN Endoscope, 15.5cm, 2120-519 Clarus Digital NeuroPEN Endoscope, 19cm and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Endoscope, Neurological	GWG	2	Manufacturer	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Manufacturer	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lamp, Endoscope, Incandescent	FTI	2	Manufacturer	accessdata.fda.gov
Light Source, Endoscope, Xenon Arc	GCT	2	Manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 25, 2024	K240535	Digital ClarusScope System; Digital NeuroPEN System	HRX	Substantially Equivalent	Clarus Medical, LLC	accessdata.fda.gov
November 21, 2023	K223615	Digital ClarusScope System, Digital NeuroPEN System	GWG	Substantially Equivalent	Clarus Medical, LLC	accessdata.fda.gov
March 18, 2021	K200925	Clarus Peel-Away Introducer Sheath	GWG	Substantially Equivalent	Clarus Medical, LLC	accessdata.fda.gov
April 28, 2009	K082038	CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V	BTR	Substantially Equivalent	Clarus Medical, LLC	accessdata.fda.gov
June 1, 2004	K040919	NUCLEOTOME PROBE SET, MODEL 21200	HRX	Substantially Equivalent	Clarus Medical, LLC	accessdata.fda.gov
May 11, 2004	K040424	LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120	GEX	Substantially Equivalent	Clarus Medical, LLC	accessdata.fda.gov
February 18, 1998	K974579	PERCSCOPE MODEL 2600	HRX	Substantially Equivalent	Clarus Medical Systems, Inc.	accessdata.fda.gov
May 20, 1997	K971455	CLARUS MODEL 5197 SIGHTLITE	FTI	Substantially Equivalent	Clarus Medical Systems, Inc.	accessdata.fda.gov
September 11, 1996	K962255	CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)	EOB	Substantially Equivalent	Clarus Medical Systems, Inc.	accessdata.fda.gov
September 19, 1995	K945633	NEURO CHANNEL ENDOSCOPE MODEL 2232	GWG	Substantially Equivalent	Clarus Medical Systems, Inc.	accessdata.fda.gov
November 4, 1994	K942249	CLARUS NEUROPEN MODEL 2120	GWG	Substantially Equivalent	Clarus Medical Systems, Inc.	accessdata.fda.gov
November 16, 1992	K922881	CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC	GEX	Unknown	Clarus Medical Systems, Inc.	accessdata.fda.gov
September 27, 1991	K912447	SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200	FET	Substantially Equivalent	Medical Laser, Inc.	accessdata.fda.gov
November 29, 1984	K844131	NUCLEOTOME	HSZ	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 27, 2021	88399	Class II	Terminated	Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002	The sterile barrier seal may be compromised.	accessdata.fda.gov

Compare with other makers

Updated April 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.