FDA.reportPublic FDA data

Clarus Flexible Fiberoptic Endoscope

Primary DI
B0673000C0
Brand
Clarus Flexible Fiberoptic Endoscope
Company
CLARUS MEDICAL, LLC
Model
3000C
Catalog number
3000C
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
B0673000C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic epiduroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of intractable back and leg pain (e.g., chronic lumbago or sciatica). It is inserted into the body percutaneously through the sacral hiatus during epiduroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to facilitate and/or perform perfusion or wash in the epidural space, dissect epidural adhesions, or deliver medications. This is a reusable device.

Sterilization Methods#

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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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
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00860000321310Axonpen SystemClearmind Biomedical Inc.GWG2022-02-18
00860000321334ClearPathClearmind Biomedical Inc.GWG2022-02-18
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10813040013704VS3-IRVISIONSENSE LTD.GWG2020-06-11
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