Vivant Medical, Inc.: FDA clearances and approvals
Vivant Medical, Inc. has 10 FDA 510(k) clearances (first 2000, latest 2005), across 5 product codes in 2 review panels. Median 510(k) review time: 37 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| KNW | Instrument, Biopsy | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 | 1 |
Review panels
Most recent Vivant Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050223 | VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER | GEI | 2005-02-24 | 24 |
| K040279 | VIVARING MICROWAVE ABLATION PROBE | GEI | 2004-03-02 | 26 |
| K032702 | VIVATIP MICROWAVE ABLATION PROBE | GEI | 2003-10-03 | 31 |
| K032047 | TRI-LOOP MICROWAVE ABLATION PROBE | GEI | 2003-08-06 | 35 |
| K031556 | VIVATHERM THEMPERATURE MEASUREMENT SYSTEM | FLL | 2003-06-23 | 35 |
| K023311 | LOOP MICROWAVE ABLATION PROBE | GEI | 2003-04-09 | 188 |
| K022286 | ENCIRCLE LOCALIZATION DEVICE | KNW | 2002-10-11 | 88 |
| K011676 | VIVAWAVE MICROWAVE SYSTEM | NEY | 2002-06-18 | 384 |
| K003439 | VIVANT BREAST LESION LOCALIZATION DEVICE | KNW | 2000-12-15 | 39 |
| K000278 | VIVANT MEDICAL BIOPSY MARKER SYSTEM | FZP | 2000-06-23 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Vivant Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vivant Medical, Inc. have?
Vivant Medical, Inc. has 10 FDA 510(k) clearances (first 2000, latest 2005), across 5 product codes in 2 review panels.
How long does FDA take to clear Vivant Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vivant Medical, Inc.'s cleared 510(k)s is 37 days.
What devices does Vivant Medical, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); KNW (Instrument, Biopsy, 2); FLL (Continuous Measurement Thermometer, 1).
Has Vivant Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vivant Medical, Inc. Related entities may recall under other names.
Next steps
- See all 10 Vivant Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Vivant Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.