FDA.reportPublic FDA data

Venclose System Power Cord

Primary DI
00858254006053
Brand
Venclose System Power Cord
Company
VENCLOSE INC
Model
VCPCE
Device description
Power Cord, Germany, Finland, Netherlands, Spain, Turkey, France, Belgium, Czech Republic, Poland
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160754000Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.2016-09-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858254006053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858254006053008582540060538582540060530858254006053

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085838983
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858254006008Venclose System EVSRF CatheterVC10A256F602016-11-01
00858254006015Venclose System EVSRF CatheterVC10A256F1002016-11-01
00858254006022Venclose System digiRF GeneratorVCRFG12016-11-01
00858254006046Venclose System Power CordVCPCB2016-11-01
00858254006060Venclose System Power CordVCPCG2016-11-01
00858254006077Venclose System Power CordVCPCC2016-11-01
00858254006084Venclose System Power CordVCPCI2016-11-01
00858254006091Venclose System Power CordVCPCN2016-11-01
00858254006107Venclose System Power CordVCPCL2016-11-01
00858254006114Venclose System Power CordVCPCK2016-11-01
00858254006121Venclose System Power CordVCPCM2016-11-01
00858254006138Venclose System Power CordVCPCH2016-11-01
00858254006145Venclose System Power CordVCPCJ2016-11-01
00858254006152Venclose System Power CordVCPCA2016-11-01
00858254006398Venclose Maven CatheterVC056F2021-09-01
00858254006404Venclose Maven CatheterVC056F2021-09-01
00858254006039Venclose System Foot PedalVCFP12016-11-01
00858254006169Venclose™ EVSRF™ CatheterVC-10A2.5-6F-60 [5X]2016-11-01
00858254006176Venclose™ EVSRF™ CatheterVC-10A2.5-6F-100 [5X]2016-11-01
00858254006183Venclose™ EVSRF™ CatheterVC-10A2.5-6F-60 [10X]2016-11-01

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