Vivawave Microwave System
FDA 510(k) K011676 · Vivant Medical, Inc.
510(k) numberK011676
Submission
- Device name
- Vivawave Microwave System
- Applicant
- Vivant Medical, Inc.
Mountain View, CA, US - Received
- May 30, 2001
- Decision date
- June 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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More from Hygea Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K050223 | Vivawave Microwave Ablation System, Coaxial IntroducerGEI · Special | 02/24/2005SE |
| K040279 | Vivaring Microwave Ablation ProbeGEI · Special | 03/02/2004SE |
| K032702 | Vivatip Microwave Ablation ProbeGEI · Special | 10/03/2003SE |
| K032047 | Tri-Loop Microwave Ablation ProbeGEI · Special | 08/06/2003SE |
| K031556 | Vivatherm Themperature Measurement SystemFLL · Traditional | 06/23/2003SE |
| K023311 | Loop Microwave Ablation ProbeGEI · Traditional | 04/09/2003SE |
| K022286 | Encircle Localization DeviceKNW · Traditional | 10/11/2002SE |
| K003439 | Vivant Breast Lesion Localization DeviceKNW · Traditional | 12/15/2000SE |
| K000278 | Vivant Medical Biopsy Marker SystemFZP · Traditional | 06/23/2000SE |
Questions and answers
When was Vivawave Microwave System cleared by the FDA?
Vivawave Microwave System (K011676) received a 510(k) decision of Substantially Equivalent on June 18, 2002, 384 days after the submission was received.
What is the product code of K011676?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.