Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

K-Number: K232505 · 2024-05-30

ApplicantZhejiang Curaway Medical Technology Co., Ltd.
Decision Date2024-05-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is a medical device manufactured by Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-30 under approval number K232505. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is a medical device that received FDA 510(k) clearance on 2024-05-30. It is manufactured by Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K232505.

When was Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter approved by the FDA?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter received FDA 510(k) clearance on 2024-05-30, under approval number K232505.

What company makes Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is manufactured by Zhejiang Curaway Medical Technology Co., Ltd..

What is the FDA product code for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

The FDA product code for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is GEI.

Related Clinical Trials

NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07136324 Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry ACTIVE_NOT_RECRUITING NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT06816368 Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia ACTIVE_NOT_RECRUITING NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING

Other Devices by Zhejiang Curaway Medical Technology Co., Ltd.

K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe K240758Radiofrequency Generator System, Cura RF Electrode K244018Disposable Biopsy Needle K242322Bone Marrow Biopsy Needle K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑