FDA.reportPublic FDA data

COMEG MEDICAL

Primary DI
M430S67000021
Brand
COMEG MEDICAL
Company
SOPRO
Model
S670 - IRRIGATEUR - SOPRO - US
Catalog number
S_670_0002
Device description
This machine controls the introduction of liquid into an articulation during arthroscopic surgery. It can be used for diagnostic purposes as well as arthroscopic surgery and enables intra-articular distension to be maintained and rinsing to be carried out.
Published
2016-09-24
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
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080122000SOPRO 670 ARTHROSCOPIC PUMPSopro2008-07-11HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M430S67000021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic irrigation/aspiration pumpA mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.

Contacts#

Phone, Email table
PhoneEmail
+33556340607info@acteongroup.com

Regulatory Flags#

DUNS number
264205501
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760278260434ACTEON SYSTEME PSPIX WIN MAC (Only)9970902018-11-19
03760278260939ACTEON SYSTEME PSPIX WIN MACS_702_00112018-11-19
M430S70200111ACTEON SYSTEME PSPIX WIN MACS_702_00112016-09-24
03760278267587ACTEONC50 - INTRAORAL CAMERAS_C50_00082024-05-02
03760278267594ACTEONC50 - INTRAORAL CAMERA DS_C50_00092024-05-02
03760278267020ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278267037ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278260045COMEG MEDICAL TECHNOLOGIESUBIPACK ENT SYSTEMSK1010162017-12-19
03760278260427COMEG MEDICALSOURCE LED SOPRO 281 BLANC (Only)9983602018-11-19
M430S21800061COMEG MEDICALSOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO S_218_00062016-09-24
M430S21800091COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00092016-09-24
M430S21800111COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00112016-09-24
M430S21800121COMEG MEDICALS218 SOPRO US WOLFS_218_00122016-09-24
M430S23000051COMEG MEDICALSOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPROS_230_00052016-09-24
M430S23000091COMEG MEDICALS230 SOPRO US OLYMPUSS_230_00092016-09-24
M430S23000111COMEG MEDICALS230 SOPRO US WOLFS_230_00112016-09-24
M430S28100011COMEG MEDICALSOURCE LED SOPRO 281 ORLS_281_00012016-09-24
M430S28100021COMEG MEDICALSOURCE LED SOPRO 281 BLANCS_281_00022016-09-24
M430S29800021COMEG MEDICALSOURCE LED SOPRO S298S_298_00022016-09-24
03760278260342COMEG MEDICAL TECHNOLOGIESPENTAX Medical LED Light SourceS_281P_01042019-07-16

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