Vivatip Microwave Ablation Probe
by Vivant Medical, Inc. 510(k)
Active
510(k) K032702
Overview
The Vivatip Microwave Ablation Probe is a needle-like device classified under the nomenclature for Electrosurgical, Cutting & Coagulation & Accessories (Product Code: GEI). It delivers microwave energy to ablate or coagulate soft tissue, primarily used for tumor treatment in general and plastic surgery applications.
This device is supplied as a single-use instrument and is regulated under FDA 510(k) clearance (K032702), granted as substantially equivalent in 2003. It is intended for insertion into tissue to achieve localized coagulation via microwave energy, with no additional sterility or MRI safety specifications noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032702 | Date3 Oct 2003 | 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- Withdrawn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 types of surgical procedures is the Vivatip Microwave Ablation Probe primarily used for, and why is it designed this way?
The Vivatip Microwave Ablation Probe is primarily intended for use in general and plastic surgery to ablate or coagulate soft tissue, particularly for tumor treatment. Its needle-like design allows precise insertion into tissue, enabling localized delivery of microwave energy to achieve controlled coagulation. This makes it suitable for procedures requiring targeted tissue treatment without affecting surrounding areas.
Is the Vivatip Microwave Ablation Probe reusable, and if not, what does this mean for clinical workflows?
No, the Vivatip Microwave Ablation Probe is designed as a single-use instrument. This means each probe is intended for one-time use only, reducing the risk of cross-contamination and ensuring consistent performance. Clinically, this simplifies sterilization workflows since no reprocessing is required, but it does necessitate proper inventory management to maintain availability for procedures.
How is the Vivatip Microwave Ablation Probe classified, and what does this classification imply about its regulatory pathway?
The Vivatip Microwave Ablation Probe falls under the FDA’s Product Code GEI (Electrosurgical, Cutting & Coagulation & Accessories) and was granted 510(k) clearance (K032702) in 2003 under a Special 510(k) pathway. This classification implies the device was determined to be *substantially equivalent* to a legally marketed predicate, meaning it follows a streamlined regulatory process while still adhering to FDA safety and effectiveness standards for microwave ablation tools.
Are there any specific storage requirements for the Vivatip Microwave Ablation Probe, and why might these matter?
The regulatory data does not specify sterility or MRI safety requirements, but as a single-use device, the Vivatip Microwave Ablation Probe should be stored in a clean, dry environment protected from physical damage or contamination. Proper storage ensures the probe remains intact and ready for immediate use, as reopening sterile packaging is not recommended. This is particularly important for maintaining procedural efficiency and sterility protocols.