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)

VVR Generator system

K-Number: K222997 · 2023-10-25

ApplicantStarmed Co., Ltd.
Decision Date2023-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VVR Generator system is a medical device manufactured by Starmed Co., Ltd.. It received FDA 510(k) clearance on 2023-10-25 under approval number K222997. 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 VVR Generator system?

VVR Generator system is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Starmed Co., Ltd.. The 510(k) number is K222997.

When was VVR Generator system approved by the FDA?

VVR Generator system received FDA 510(k) clearance on 2023-10-25, under approval number K222997.

What company makes VVR Generator system?

VVR Generator system is manufactured by Starmed Co., Ltd..

What is the FDA product code for VVR Generator system?

The FDA product code for VVR Generator system is GEI.

Related Clinical Trials

NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Other Devices by Starmed Co., Ltd.

K163450VIVA combo RF System K181249EUSRA RF Electrode K172012star RF Electrode, VIVA RF Electrode K181758ELRA Electrode K183538VIVA combo RF System K203795Star RF Electrode, VIVA RF Electrode

View all 10 devices →

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.

↑