FDA.reportPublic FDA data

ClarusScope

Primary DI
B0673000N0
Brand
ClarusScope
Company
CLARUS MEDICAL, LLC
Model
3000N
Catalog number
3000N
Device description
Endoscope, Flexible Fiberoptic
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWGEndoscope, Neurological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942249000CLARUS NEUROPEN MODEL 2120Clarus Medical Systems, Inc.1994-11-04GWG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0673000N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic neuroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the central nervous system (CNS). It is inserted into the body through a pre-drilled hole in the cranium for neuroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Liquid Chemical"", ""Peracetic Acid"", ""Ethylene Oxide""]"
Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
763-525-8400admin@clarus-medical.com

Regulatory Flags#

DUNS number
010316284
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810004820125Light Cable, ACMI-Wolf/Dyonics, 1mm5161-1005161-1002024-12-23
10810004820132Light Cable, ACMI-Olympus, 1mm5160-1005160-1002024-12-23
10810004820149Light Cable, ACMI-Storz, 1mm5154-1005154-1002024-12-23
10810004820460Light Cable, ACMI-ACMI, 1mm5161-1005161-1002024-12-30
10810004820705Adapter, ACMI5196-9015196-9012024-12-23
10810004820712Adapter, Olympus5196-9025196-9022024-12-23
10810004820729Adapter, Storz5196-9035196-9032024-12-23
10810004820736Adapter, Wolf/Dyonics5196-9045196-9042024-12-23
10810004820750Universal Light Cable5196-1005196-1002024-12-23
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WC2230-5212230-5212026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WC2230-5132230-5132026-04-21
00810004821118Digital MurphyScope Endoscope2125-5152125-5152026-04-21
B06730000100SOS Shikani Optical Stylet, Adult30000-1030000-102016-09-20
B06730000GL0SOS Malleable Stylet, Green Line (Adult)30000-GL30000-GL2016-09-20
B06730000GLS0SOS Malleable Stylet, Adult, Green Line with Stop30000-GLS30000-GLS2016-09-20
B06730001100SOS Shikani Optical Stylet, Pediatric30001-1030001-102016-09-20
B06730003P0PocketScope, pocket endoscope30003-P30003-P2016-09-20
10810004820170Forceps, Cup, Down, 2mm, 28.5cm3220-0023220-0022024-12-30
10810004820316Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down35701357012024-12-30
10810004820323Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down35700357002024-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400161cCeLLVPIX Medical, Inc.GWG2026-05-11
08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
00860000321389Neuroblade SystemClearmind Biomedical Inc.GWG2026-05-11
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821118Digital MurphyScope EndoscopeCLARUS MEDICAL, LLCGWG2026-04-21
00840067103029ZenithCADWELL INDUSTRIES, INC.GWG2025-12-31
04048551418123n.a.Karl Storz GmbH & Co. KGGWG2025-08-11
04048438000175NAKarl Storz GmbH & Co. KGGWG2025-03-27
00810004820401Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm ODCLARUS MEDICAL, LLCGWG2024-12-23
00810004820418Clarus Digital ChannelScope Endoscope, 21.6cmCLARUS MEDICAL, LLCGWG2024-12-23
04048551425695n.a.Karl Storz GmbH & Co. KGGWG2024-12-20
04048551436271n.a.Karl Storz GmbH & Co. KGGWG2024-11-28
10884521844681VS3 IridiumVISIONSENSE LTD.GWG2024-11-11
04048551436240n.a.Karl Storz GmbH & Co. KGGWG2024-10-18
04055207008317RIWORichard Wolf GmbHGWG2024-08-19
04055207069981RIWORichard Wolf GmbHGWG2024-08-19
10810004821016Clarus Digital Control ModuleCLARUS MEDICAL, LLCGWG2024-02-19
076133276089151788STRYKER CORPORATIONGWG2023-12-11
00850002332285Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
00850002332292Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
10884521834644VS3-IRVISIONSENSE LTD.GWG2022-05-09
00860000321310Axonpen SystemClearmind Biomedical Inc.GWG2022-02-18
00860000321334ClearPathClearmind Biomedical Inc.GWG2022-02-18
00850002332247AURORA® Surgiscope®Integra Lifesciences CorporationGWG2021-05-18
00850002332254AURORA® Surgiscope®Integra Lifesciences CorporationGWG2021-05-18
10813040013704VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013711VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013728VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013117VS3-IRVISIONSENSE LTD.GWG2020-04-07