Question 1

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

Accepted Answer

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.

Question 2

Where is Clarus Medical, LLC based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
SOS Malleable Stylet, Green Line (Adult)	30000-GL	FDA UDI	Class II	Active
ClarusScope	3000N	FDA UDI	Class II	Active
Nucleotome	23535	FDA UDI	Class I	Active
Clarus Digital Inspection Scope, Long	CD2-2000	FDA UDI	Class I	Active
Clarus Inspection Scope, Mini	C1-800	FDA UDI	Class I	Active
LASE Accessory Kit	1100-900	FDA UDI	Class II	Active
SOS Shikani Optical Stylet, Adult	30000-10	FDA UDI	Class II	Active
Clarus Digital NeuroPEN Endoscope, 19.0cm	2120-519	FDA UDI	Class II	Active
ChannelScope	2233-002	FDA UDI	Class II	Active
Clarus Inspection Scope, Long	C2-950	FDA UDI	Class I	Active
Clarus Digital Inspection Scope, 1mm x 110cm	CB1-110	EUDAMEDFDA UDI	Class I	Active
Nucleotome Probe Set, Model 21200	K040919	FDA 510(k)	Class II	Active
Digital ClarusScope System; Digital NeuroPEN System	K240535	FDA 510(k)	Class II	Active
Spine Scope, Model 2180	K011454	FDA 510(k)	Class II	Active
Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160	K021848	FDA 510(k)	Class II	Active
Clarus Video Airway Endoscope, Models 30000-V And 30003-V	K082038	FDA 510(k)	Class II	Active
Laser Endoscopic Decompression Kit, Model 1100, And Percutaneous Discectomy Kit, Model 1120	K040424	FDA 510(k)	Class II	Active
Clarus Peel-Away Introducer Sheath	K200925	FDA 510(k)	Class II	Active
Digital ClarusScope System, Digital NeuroPEN System	K223615	FDA 510(k)	Class II	Active
Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160	K022610	FDA 510(k)	Class II	Active
Clarus Dual USB Enclosure	CD-USB	EUDAMEDFDA UDI	Class I	Active
Clarus Digital Inspection Scope, 2mm x 110cm	CB2-110	EUDAMEDFDA UDI	Class I	Active
Clarus Dual HDMI Enclosure	CD-HDMI	EUDAMEDFDA UDI	Class I	Active
Clarus Digital Inspection Scope, 2mm x 60cm	CB2-60	EUDAMEDFDA UDI	Class I	Active
Clarus Digital Inspection Scope, 2mm x 200cm	CB2-200	EUDAMEDFDA UDI	Class I	Active

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