# K011676: Vivawave Microwave System

- Pathway: 510(k) (Traditional)
- Applicant: Vivant Medical, Inc.
- Decided: Jun 18, 2002 after 384 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861904 (1986). 5 ancestors in all.
67 later devices descend from it; 9 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864413: Model Hse-5M Microwave Surgery Equipment/Microtaze, Cooper Lasersonics, Inc. (1986) Summary page 4.
- K861904: HS-15M Microwave Surgery Equipment, Microtaze, Cooper Lasersonics, Inc. (1986) Summary page 4.
- K981672: Radiotherapeutics RF-2000 Radiofrequency Generator, Radiotherapeutics Corp. (1998) Summary page 4.
- K962313: Modified Leveen Needle Electrode, Radiotherapeutics Corp. (1996) Summary page 4.
- K962692: Zomed Model 30-6 Multielectrode Array Probe, Zomed Intl. (1996) Summary page 4.

## Most influential descendants
- K053535: Vivawave Microwave Ablation System (2006), 50 descendants of its own
- K070023: Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 (2007), 41 descendants of its own
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own
- K113237: Certus 140 2.45GHZ Ablation System (2012), 38 descendants of its own
- K133821: Emprint Ablation System (2014), 29 descendants of its own

## Recalls of this device
- Feb 6, 2009 · Not classified · Z-3092-2011: Generator may deliver full power when a lower power is selected.

## Indications for use
The VivaWave™ Microwave System is intended for coagulation of soft tissue

Source page: https://510kreport.com/device/K011676
Methodology: https://510kreport.com/methodology