FDA.reportPublic FDA data

Venclose System Power Cord

Primary DI
00858254006121
Brand
Venclose System Power Cord
Company
VENCLOSE INC
Model
VCPCM
Device description
Power Cord, India
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
00858254006121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858254006121008582540061218582540061210858254006121

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
00858254006053Venclose System Power CordVCPCE2016-11-01
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
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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