510(k) Report

FDA applicant

Vivant Medical, Inc.

Mountain View, CA10 decisions2000–20051 recall

FDA records 10 decisions for Vivant Medical, Inc. (Mountain View, CA) from 2000 to 2005: 10 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNW (Instrument, Biopsy). Its devices cite 17 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Vivant Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vivant Medical, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vivant Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vivant Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions
  • KNWInstrument, Biopsy2decisions
  • FLLContinuous Measurement Thermometer1decision
  • NEYSystem, Ablation, Microwave And Accessories1decision
  • FZPClip, Implantable1decision

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011676Vivawave Microwave SystemVivant Medical, Inc. · 20029cite it
  • K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 20036cite it
  • K031556Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 20033cite it
  • K023311Loop Microwave Ablation ProbeVivant Medical, Inc. · 20032cite it
  • K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 20042cite it
  • K000278Vivant Medical Biopsy Marker SystemVivant Medical, Inc. · 20001cites it

What has FDA decided for it lately?

  • K050223Vivawave Microwave Ablation System, Coaxial IntroducerVivant Medical, Inc. · 2005
  • K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004
  • K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
  • K032047Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  • K031556Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 2003
  • K023311Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  • K022286Encircle Localization DeviceVivant Medical, Inc. · 2002
  • K011676Vivawave Microwave SystemVivant Medical, Inc. · 20021 recall

All 10 as Vivant Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K011676Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco…Feb 6, 2009