FDA.reportPublic FDA data

TS-RF Generator

Primary DI
08809306769251
Brand
TS-RF Generator
Company
STARMED CO.,LTD
Model
STS10
Device description
The TS-RF Generator consists of an RF generator, cables, and components. This TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. Radiofrequency power is supplied and controlled with a maximum of 50 watts. Data Logs can be stored by connecting the USB Flash Driver with the communication terminal of the rear panel of the RF generator.
Published
2025-12-01
Public version status
New
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
K251566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251566000TS-RF Generator (STS10)Starmed Co., Ltd.2025-11-17GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809306769251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809306769251088093067692518809306769251

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac 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 electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694699723
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809306769244VVR GeneratorVVR102024-09-30
08809306764010VENISTAR7-VENI007090N2024-08-29
08809306764874VENISTAR3-VENI003090N2024-08-29
08809306767868VENISTAR3-VENI0030N2024-08-29
08809306767875VENISTAR7-VENI0070N2024-08-29
18809306764017VENISTAR7-VENI007090N2024-08-29
18809306764871VENISTAR3-VENI003090N2024-08-29
18809306767865VENISTAR3-VENI0030N2024-08-29
18809306767872VENISTAR7-VENI0070N2024-08-29
08809922260637ELRA Electrode7-2B11L2024-08-28
18809922260634ELRA Electrode7-2B11L2024-08-28
08809922260620ELRA Electrode7-2B11S2023-11-24
08809922260644ELRA Electrode7-2B22S2023-11-24
08809922260651ELRA Electrode7-2B22L2023-11-24
08809922260668ELRA Electrode7-4B18S2023-11-24
08809922260675ELRA Electrode7-4B18L2023-11-24
08809922260682ELRA Electrode7-4B33S2023-11-24
08809922260699ELRA Electrode7-4B33L2023-11-24
08809306760012star RF Electrode17-15s20F17-15s20F2018-03-21
08809306760029star RF Electrode17-15s30F17-15s30F2017-05-19

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