FDA.reportPublic FDA data

VIVA combo RF Generator

Primary DI
08809306769060
Brand
VIVA combo RF Generator
Company
STARMED CO.,LTD
Model
VCS10
Catalog number
VCS10
Device description
The VIVA combo RF System consists of RF generator, active electrode, grounding pad andperistaltic pump for electrode cooling. This device is designed to produce local tissue heating atthe tip of the electrodes causing the coagulation and ablation of tissue.The VIVA combo RF System is capable of delivering up to 200 W of RF power and the availablepower is limited through software control. This generator monitors the power, resistance,current and temperature.
Published
2017-05-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K163450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163450000VIVA combo RF SystemStarmed Co., Ltd.2017-03-08GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809306769060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809306769060088093067690608809306769060

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system generatorA mains electricity (AC-powered) device designed to generate radio-frequency (RF) electrical current used to create heat 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. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF energy to the operative site.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height115Millimeter
Length348Millimeter
Weight6Kilogram
Width260Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82318163546inquiry@starmed4u.com

Regulatory Flags#

DUNS number
694699723
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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08809306764133VIVA RF Electrode19-07V05-15X_V22026-06-04
08809306764140VIVA RF Electrode19-08V05-15X_V22026-06-04
08809306764157VIVA RF Electrode19-10V05-15X_V22026-06-04
08809306764164VIVA RF Electrode18-05V05-15X_V22026-06-04
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