510(k) · Cleared
Recalled · 2007Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vnus Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 1, 2006 as substantially equivalent to K030557 (Vnus Medical Technologies, Inc., 2003) after a 76-day review. Its family tree reaches back 8 generations to 1995. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 1, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K943450 (1995). 23 ancestors in all, the oldest K800617 (1980). 13 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- This deviceK061373 Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK111887 Closurefast Radiofrequency CatheterCovidien · 2011
- Descendant · cites it directly · 3 of its ownK160754 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK211806 Venclose digiRF Generator with Maven Catheter, Venclose Maven…Venclose, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK250068 Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK253918 Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K111887Closurefast Radiofrequency CatheterCovidien · 2011 · cites it directly6descendants
- K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 2016 · cites it directly3descendants
- K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc. · 2021 · 2 generations on2descendants
- K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · 2 generations on1descendant
- K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K030557 | Modification to Vnus Closure System | Vnus Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K061373 | Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100 | Vnus Medical Technologies, Inc. | 2006 | — |
| +1 | K111887 | Closurefast Radiofrequency Catheter | Covidien | 2011 | — |
| +1 | K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | Venclose, Inc. | 2016 | 2 |
| +2 | K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose… | Venclose, Inc. | 2021 | 1 |
| +2 | K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | 2025 | 1 |
| +2 | K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030557 | Modification to Vnus Closure SystemSummary page 1…ce (21 CFR §878.4400) E~quivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the VNUS® ClosurePlusTM Catheter (K030557). The technological characteristics and principals of operation of the VNUS ClosureFAST catheter are substantially equivalent to… | 2003 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111887 | Closurefast Radiofrequency Catheter | 2011 | 6 |
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | 2016 | 3 |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | 2024 | 0 |
| K223488 | ClosureFast™ Endovenous Radiofrequency Ablation Catheter | 2023 | 0 |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | 2019 | 0 |
| K090661 | Nes Reprocessed Varicose Vein RF Catheter | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2007 | Not classified | Z-0542-2008 | Labeling design | Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation. |
| Mar 6, 2007 | Not classified | Z-0132-2008 | Package design/selection | Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K111887 (Covidien, 2011) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K030557.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The VNUS ® ClosureFASTTM Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061373: Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061373
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026