FDA.reportPublic FDA data

LASE Endoscopic Discectomy Set

Primary DI
B0671100010L0
Brand
LASE Endoscopic Discectomy Set
Company
CLARUS MEDICAL, LLC
Model
1100-010L
Catalog number
1100-010L
Device description
LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Trimedyne connector.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922881000CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISCClarus Medical Systems, Inc.1992-11-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0671100010L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar decompression procedure kitA collection of sterile devices used to perform percutaneous, minimally-invasive lumbar decompression (MILD) for the treatment of various spine conditions, typically in conjunction with an endoscope. It typically includes trocars, cannulae (portals), a retractor, and other essential materials for the procedure; it may also include a disposable endoscope. It is used for image-guided tissue resection of the lumbar spine involving retraction, grasping, cutting, ablation, and coagulation of the spinal tissues. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius52 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
010316284
Device count
1
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

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10810004821146Curved Cannula Set1100-5101100-5102026-06-23
00810004821101Digital SpineScope Endoscope1100-5001100-5002026-06-22
00810004821163Digital MurphyScope Endoscope, 0 degree2125-515s2125-515s2026-06-22
10810004821122Spinal Introducer Set1100-5011100-5012026-06-22
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
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B06730000GL0SOS Malleable Stylet, Green Line (Adult)30000-GL30000-GL2016-09-20
B06730000GLS0SOS Malleable Stylet, Adult, Green Line with Stop30000-GLS30000-GLS2016-09-20

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