VivaRing Microwave Ablation Probe
by Vivant Medical, Inc. 510(k)
Active
510(k) K040279
Overview
The VivaRing Microwave Ablation Probe is a microwave ablation device classified under product code GEI, designed for soft tissue coagulation and tumor ablation. It employs a pre-shaped curved microwave antenna within a delivery cannula, activated by an external microwave generator to induce localized thermal effects in target tissue. The device is intended for use in surgical procedures where controlled tissue ablation is required, such as in oncology or plastic surgery applications.
The probe is supplied as a reusable surgical instrument, requiring connection to the VivaWave Microwave Generator for operation. It is cleared for use in the United States under an FDA 510(k) clearance (K040279), granted in 2004 via the Special 510(k) pathway. Sterility and MRI safety are not specified in the available data, and no details on single-use versus reusable status beyond its classification as a reusable device are provided. Storage conditions are not documented.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040279 | Date2 Mar 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vivant Medical, Inc.
Questions
What is the VivaRing Microwave Ablation Probe used for?
The VivaRing Microwave Ablation Probe is designed for soft tissue coagulation and tumor ablation during surgical procedures. Its curved microwave antenna, activated by an external VivaWave Microwave Generator, delivers localized thermal effects to target tissues, making it suitable for applications in oncology—such as removing tumors—and plastic surgery, where controlled tissue ablation is required.
How is the VivaRing Microwave Ablation Probe supplied and operated?
The probe is supplied as a reusable surgical instrument and requires connection to the VivaWave Microwave Generator to function. Unlike single-use devices, it is intended for repeated use in clinical settings, provided it is properly maintained and sterilized between procedures. The generator provides the microwave energy necessary to activate the probe’s antenna.
Is the VivaRing Microwave Ablation Probe single-use or reusable?
The VivaRing Microwave Ablation Probe is classified as a reusable device. While the data does not specify sterility or MRI safety details, its reusable status aligns with typical surgical instruments that undergo cleaning and sterilization protocols between uses. Always follow manufacturer guidelines for reprocessing.
What regulatory clearance does the VivaRing Microwave Ablation Probe hold?
The probe holds FDA clearance under the Special 510(k) pathway, granted in 2004 with clearance number K040279. This classification indicates it was deemed substantially equivalent to a legally marketed predicate device at the time of review by the FDA’s Special (SU) Advisory Committee for General and Plastic Surgery.
Are there any documented storage conditions for the VivaRing Microwave Ablation Probe?
The provided data does not include specific storage conditions for the VivaRing Microwave Ablation Probe. For optimal performance and longevity, it is recommended to store the device in a clean, dry environment, protected from physical damage, and follow manufacturer-recommended maintenance protocols to ensure safe and effective reuse.