Star RF Electrode, VIVA RF Electrode
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203795 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Star RF Electrode, VIVA RF Electrode is a radiofrequency ablation electrode (product code: GEI) designed for percutaneous and intraoperative soft tissue ablation. It is intended for use in procedures such as the treatment of benign thyroid nodules, leveraging ultrasound-guided precision to target lesions with adjustable ablation zones. The device operates within a radiofrequency ablation system, delivering controlled energy to achieve tissue coagulation.
The electrodes are supplied as reusable medical devices, with the VIVA Series offering adjustable active tip lengths in 5 mm increments to accommodate varying lesion sizes and anatomical locations. They are intended for use in sterile environments, such as operating rooms or interventional suites, and must comply with FDA 510(k) clearance, MDD, and MDR regulations. No specific MRI safety classification or sterility assurance (e.g., single-use) is stated in the provided data.
Frequently asked questions
Are the Star RF Electrode and VIVA RF Electrode designed for single-use or can they be reused in multiple procedures?
The Star RF Electrode and VIVA RF Electrode are explicitly labeled as reusable medical devices. This means they are intended for use across multiple procedures, provided they are properly cleaned, sterilized, and maintained between uses. Since they are not described as single-use, they must be handled according to standard reusable device protocols in sterile environments like operating rooms or interventional suites.
What makes the VIVA RF Electrode different from the Star RF Electrode in terms of customization for treatment?
The VIVA RF Electrode series includes an adjustable active tip length, available in increments of 5 mm. This feature allows clinicians to select the appropriate length to match the size and location of the lesion being treated, ensuring better precision during ultrasound-guided ablation procedures for conditions like benign thyroid nodules.
How is the Star RF Electrode intended to be used in clinical settings, and what guidance is provided for its application?
The Star RF Electrode is designed for percutaneous and intraoperative soft tissue ablation, specifically for procedures like treating benign thyroid nodules. It operates within a radiofrequency ablation system, delivering controlled energy to achieve targeted tissue coagulation. The device relies on ultrasound-guided precision to ensure accurate lesion targeting, and its use is restricted to sterile environments such as operating rooms or interventional suites.
What regulatory pathways have been followed for the Star RF Electrode and VIVA RF Electrode, and what does this imply for their use?
The Star RF Electrode and VIVA RF Electrode have undergone FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This implies that the devices meet regulatory standards for safety and effectiveness as determined by these authorities, allowing their use in clinical settings where these approvals apply. The clearance type is described as 'Traditional,' indicating a standard review process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RF Electrode for Ablation: star RFA Electrode - STARMED America, Radiofrequency Ablation Generator | STARMED America, VIVA RF Electrode - STARMED, VIVA RF Electrode_V2 - STARMED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203795 | Class II | Active |
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Manufacturer
- Manufacturer
- Starmed Co., Ltd
- FDA Applicant
- Starmed Co., Ltd.
Sources (2)
- FDA 510(k) K203795 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026