Vnus Medical Technologies, Inc.: FDA clearances and approvals
Vnus Medical Technologies, Inc. has 9 FDA 510(k) clearances (first 1998, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time: 76 days. openFDA lists 3 product recalls by a recalling firm named Vnus Medical Technologies, Inc.
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 | 9 | 9 |
Review panels
Most recent Vnus Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 | GEI | 2008-10-15 | 15 |
| K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | 2006-08-01 | 76 |
| K052003 | VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) | GEI | 2005-10-11 | 78 |
| K040638 | VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 | GEI | 2004-06-07 | 89 |
| K033547 | VNUS VESSEL AND TISSUE COAGULATION SYSTEM | GEI | 2004-01-07 | 56 |
| K030557 | MODIFICATION TO VNUS CLOSURE SYSTEM | GEI | 2003-03-11 | 18 |
| K003092 | MODIFICATION TO VNUS CLOSURE SYSTEM | GEI | 2000-12-18 | 76 |
| K982816 | VNUS CLOSURE SYSTEM | GEI | 1999-03-17 | 218 |
| K974521 | VNUS CLOSURE SYSTEM | GEI | 1998-02-20 | 80 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2007-08-08.
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 Vnus Medical Technologies, Inc. have?
Vnus Medical Technologies, Inc. has 9 FDA 510(k) clearances (first 1998, latest 2008), across 1 product code in 1 review panel.
How long does FDA take to clear Vnus Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vnus Medical Technologies, Inc.'s cleared 510(k)s is 76 days.
What devices does Vnus Medical Technologies, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9).
Has Vnus Medical Technologies, Inc. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Vnus Medical Technologies, Inc; the most recent began 2007-08-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Vnus Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Vnus Medical Technologies, 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.