TS-RF Generator

GUDID 08809306769251

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.

STARMED CO.,LTD

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08809306769251
• NIH Device Record Key: 484ef22b-9829-4b8a-8fdb-01f9029d45f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TS-RF Generator
• Version Model Number: STS10
• Company DUNS: 694699723
• Company Name: STARMED CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306769251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251566

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by STARMED CO.,LTD

• 08809306769251 - TS-RF Generator: 2025-12-09The 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.
• 08809306769251 - TS-RF Generator: 2025-12-09 The TS-RF Generator consists of an RF generator, cables, and components. This TS-RF Generator is indicated for use in general su
• 08809306769244 - VVR Generator: 2024-10-08 VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and co
• 18809306764017 - VENISTAR: 2024-09-06
• 18809306764871 - VENISTAR: 2024-09-06
• 18809306767865 - VENISTAR: 2024-09-06
• 18809306767872 - VENISTAR: 2024-09-06
• 18809922260634 - ELRA Electrode: 2024-09-05
• 08809922260620 - ELRA Electrode: 2023-12-04