510(k) · Cleared
ClearedModification to Vnus Closure System
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 Mar 11, 2003 as substantially equivalent to K982816 (Vnus Medical Technologies, Inc., 1999) and 1 other predicate after an 18-day review. Its family tree reaches back 7 generations to 1995. 21 later devices descend from it.
- Decided
- Mar 11, 2003
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K943450 (1995). 22 ancestors in all, the oldest K800617 (1980). 21 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 1 generation backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- This deviceK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK061373 Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc. · 2006 · Recalled
- Descendant · cites it directly · 10 of its ownK040638 Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK111887 Closurefast Radiofrequency CatheterCovidien · 2011
- Descendant · cites it directly · 6 of its ownK033547 Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK052003 Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex…Vnus Medical Technologies, Inc. · 2005
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc. · 2006 · cites it directly13descendants
- K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004 · cites it directly10descendants
- K111887Closurefast Radiofrequency CatheterCovidien · 2011 · 2 generations on6descendants
- K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004 · cites it directly6descendants
- K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc. · 2005 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −6 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −1 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K030557 | Modification to Vnus Closure System | Vnus Medical Technologies, Inc. | 2003 | — |
| +1 | K061373 | Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100 | Vnus Medical Technologies, Inc. | 2006 | 2 |
| +1 | K040638 | Vnus Radiofrequency Generator, Model RFG2 | Vnus Medical Technologies, Inc. | 2004 | — |
| +2 | K111887 | Closurefast Radiofrequency Catheter | Covidien | 2011 | — |
| +1 | K033547 | Vnus Vessel and Tissue Coagulation System | Vnus Medical Technologies, Inc. | 2004 | — |
| +1 | K052003 | Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model… | Vnus Medical Technologies, Inc. | 2005 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K982816 | Vnus Closure SystemSummary page 1…d accessories (2 1 CFR 870.4400) Equivalent Device: The subject device is substantially equivalent in intended use andor method of operation to the VNUS Closure System (K9828 16 and K003092) Intended Use: The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with su… | 1999 |
| * | K003092 | Modification to Vnus Closure SystemSummary page 1…(2 1 CFR 870.4400) Equivalent Device: The subject device is substantially equivalent in intended use andor method of operation to the VNUS Closure System (K9828 16 and K003092) Intended Use: The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial ve… | 2000 |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061373 | Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100 | 2006 | 13 |
| K040638 | Vnus Radiofrequency Generator, Model RFG2 | 2004 | 10 |
| K033547 | Vnus Vessel and Tissue Coagulation System | 2004 | 6 |
| K052003 | Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =… | 2005 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K061373 (Vnus Medical Technologies, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K982816.
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 Closure System 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/K030557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030557: Modification to Vnus Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030557
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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