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CLARUS MEDICAL, LLC

United States·US-MF-000025783

Last updated May 27, 2026

What CLARUS MEDICAL, LLC makes

Clarus Medical, LLC manufactures fibreoptic light cables, reusable surgical soft-tissue manipulation forceps (including alligator-type), rigid and single-use rigid video intracranial/spinal endoscopes, lumbar decompression procedure kits, instrument inspection scopes, flexible fibreoptic intubation laryngoscopes, and percutaneous automatic diskectomy systems. Example products include the Digital ClarusScope System, Digital NeuroPEN System, Nucleotome, ChannelScope, Clarus Flexible Fiberoptic Endoscope, various light cables, cup-forceps with teeth, and the LASE Endoscopic Discectomy Set.

The company's devices are classified as Class I and Class II medical devices and are listed in the EUDAMED, FDA 510(k), and FDA UDI registries. Clarus Medical, LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Clarus Medical, LLC manufacture?

Clarus Medical, LLC manufactures fibreoptic light cables, reusable surgical soft-tissue manipulation forceps (including alligator-type), rigid and single-use rigid video intracranial/spinal endoscopes, lumbar decompression procedure kits, instrument inspection scopes, flexible fibreoptic intubation laryngoscopes, and percutaneous automatic diskectomy systems. These products are based solely on the device categories and example devices provided in the source data, with no additional products inferred or added.

Where is Clarus Medical, LLC based?

Clarus Medical, LLC is based in the United States, as explicitly stated in the SUMMARY section of the provided device data. No further location details such as city, state, or address are included in the source material, so the answer is limited to the country level only.

In which regulatory registries are Clarus Medical, LLC's devices listed?

Clarus Medical, LLC's devices are listed in the EUDAMED, FDA 510(k), and FDA UDI registries, as directly stated in the DEVICE CLASSES and LISTED IN fields and reiterated in the SUMMARY. These are the only registries mentioned in the source data, and no others are implied or added.

How are Clarus Medical, LLC's devices classified under regulatory frameworks?

Clarus Medical, LLC's devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data. This classification reflects the risk-based categorization applied to their products, and no other classes (such as Class III) are mentioned or implied in the source material.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 13355, 10th Avenue North, Minneapolis, United States
Website: www.clarus-medical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 763-525-8400
PRRC Contact: Mark Brown
EUDAMED SRN: US-MF-000025783
FDA FEI Number: —
DUNS Number: 010316284

Catalogue (75)

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Device	Model / Reference	Registries	Class	Status
Digital ClarusScope System and Digital NeuroPEN System	K252790	FDA 510(k)	Class II	Active
Nucleotome	21200	FDA UDI	Class II	Active
ChannelScope, Long, 10K	2232-002	FDA UDI	Class II	Active
Clarus Flexible Fiberoptic Endoscope	3000C	FDA UDI	Class II	Active
Light Cable, ACMI-Wolf/Dyonics, 1mm	5161-100	FDA UDI	Class I	Active
Light Cable, ACMI-ACMI, 1mm	5161-100	FDA UDI	Class I	Active
Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down	35701	FDA UDI	Class I	Active
Clarus Digital ChannelScope Endoscope, 13.0cm	2233-513	FDA UDI	Class II	Active
LASE Endoscopic Discectomy Set	1100-002 SHORT	FDA UDI	Class II	Active
LASE Endoscopic Discectomy Set	1100-002	FDA UDI	Class II	Active
Model 5150-002 Tubing Set	5150-002	FDA UDI	Class II	Active
Clarus Digital Control Module	5190-500	FDA UDI	Class II	Active
PocketScope, pocket endoscope	30003-P	FDA UDI	Class II	Active
Adapter, Olympus	5196-902	FDA UDI	Class I	Active
Nucleotome	23500	FDA UDI	Class I	Active
LASE Endoscopic Discectomy Set	1100-010L	FDA UDI	Class II	Active
Adapter, Storz	5196-903	FDA UDI	Class I	Active
Clarus Digital Inspection Scope, 1.9mm OD	CD2-1100	FDA UDI	Class I	Active
Clarus Digital ChannelScope Endoscope, 21.6cm	2233-521	FDA UDI	Class II	Active
Forceps, Grasping, Down, 2mm, 28.5cm	3240-002	FDA UDI	Class I	Active
Adapter, ACMI	5196-901	FDA UDI	Class I	Active
Clarus Digital Inspection Scope, 1mm x 110cm, High Definition	CB1-110HD	FDA UDI	Class I	Active
Peelaway Introducer Sheath, 14Fr	1305-014	FDA UDI	Class II	Active
Universal Light Cable	5196-100	FDA UDI	Class I	Active
Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down	35700	FDA UDI	Class I	Active
Clarus Endoscopy Pump	5169-100	FDA UDI	Class II	Active
LASE Endoscopic Discectomy Set	1100-010	FDA UDI	Class II	Active
Forceps, Grasping, Down, 3mm, 28.5cm	3240-001	FDA UDI	Class I	Active
Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm OD	2232-535	FDA UDI	Class II	Active
NeuroPEN	2120-025	FDA UDI	Class II	Active
ShuntPen Cannula	2120C	FDA UDI	Class II	Active
Nucleotome	22500	FDA UDI	Class I	Active
SOS Malleable Stylet, Adult, Green Line with Stop	30000-GLS	FDA UDI	Class II	Active
Clarus Digital ClarusScope Endoscope	2100-500	FDA UDI	Class II	Active
LASE Endoscopic Discectomy Set	1100-002(S)	FDA UDI	Class II	Active
Forceps, Grasping, Down, 2mm, 19.7cm	3241-002	FDA UDI	Class I	Active
Clarus Inspection Scope, Mini, Short	C1-350	FDA UDI	Class I	Active
Forceps, Cup, Down, 2mm, 19.7cm	3221-002	FDA UDI	Class I	Active
Light Cable, ACMI-Storz, 1mm	5154-100	FDA UDI	Class I	Active
ChannelScope	2233-005	FDA UDI	Class II	Active
Clarus TURBO LED Light Source	5197-201	FDA UDI	Class II	Active
Clarus Digital ChannelScope Endoscope, 11.0cm	2233-511	FDA UDI	Class II	Active
Adapter, Wolf/Dyonics	5196-904	FDA UDI	Class I	Active
Clarus Digital NeuroPEN Endoscope, 15.5cm	2120-515	FDA UDI	Class II	Active
SOS Shikani Optical Stylet, Pediatric	30001-10	FDA UDI	Class II	Active
LASE Curved Operating Channel Set	1100-905	FDA UDI	Class II	Active
Forceps, Cup, Down, 2mm, 28.5cm	3220-002	FDA UDI	Class I	Active
Nucleotome	11000	FDA UDI	Class I	Active
Light Cable, ACMI-Olympus, 1mm	5160-100	FDA UDI	Class I	Active
Clarus Video Airway System	30000-V	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MPS Medical Product Service GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There is 1 recall record for Clarus Medical, LLC, initiated on July 27, 2021, with a status of terminated. The reason given for the recall is that the sterile barrier seal may be compromised.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 27, 2021	Z-2405-2021	—	terminated	The sterile barrier seal may be compromised.