510(k) · Cleared
ClearedVnus 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 17, 1999 as substantially equivalent to K974521 (Vnus Medical Technologies, Inc., 1998) after a 218-day review. Its family tree reaches back 6 generations to 1995. 973 later devices descend from it.
- Decided
- Mar 17, 1999
- Review
- 218 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943450 (1995). 20 ancestors in all, the oldest K800617 (1980). 973 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 1 generation backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- This deviceK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- Descendant · cites it directly · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002
- Descendant · 2 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- Descendant · 3 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · 4 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
Showing 5 of 973 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 973 · See all- K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · cites it directly714descendants
- K022266Aurora SRSyneron Medical, Ltd. · 2002 · cites it directly705descendants
- K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 2 generations on695descendants
- K030186Polris LVSyneron Medical, Ltd. · 2003 · 3 generations on680descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 4 generations on678descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −5 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −1 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| 0 (this device) | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| +1 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| +1 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| +2 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
| +3 | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 9 | 0 |
| 2004 | 6 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 11 | 0 |
| 2008 | 26 | 0 |
| 2009 | 20 | 0 |
| 2010 | 27 | 0 |
| 2011 | 20 | 0 |
| 2012 | 19 | 0 |
| 2013 | 26 | 0 |
| 2014 | 37 | 0 |
| 2015 | 36 | 0 |
| 2016 | 50 | 0 |
| 2017 | 52 | 0 |
| 2018 | 48 | 0 |
| 2019 | 35 | 0 |
| 2020 | 47 | 0 |
| 2021 | 47 | 0 |
| 2022 | 70 | 0 |
| 2023 | 66 | 0 |
| 2024 | 92 | 0 |
| 2025 | 131 | 0 |
| 2026 | 76 | 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 |
|---|---|---|---|
| * | K974521 | Vnus Closure SystemSummary page 2…stem B. Common Name Electrosurgery System/Electrosurgical Coagulator C. Predicate Device(s) Cameron-Miller Vein Eraser System (Pre-enactment) VNUS?® Closure™ System (K974521) D. Device Description The VNUS Closure System consists of three main components: The VNUS Closure Catheter, the VNUS RF Genera… | 1998 |
| * | — | Cameron-Miller Vein Eraser System (Pre-enactment) Named without a submission number |
What descends from it? (973)
See all 9737 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012398 | Diomed 15 Diode Laser | 2002 | 714 |
| K022266 | Aurora SR | 2002 | 705 |
| K030557 | Modification to Vnus Closure System | 2003 | 21 |
| 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 |
| K023624 | SLT Venous Fiber Delivery Systems, Model… | 2003 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K012398 (Diomed, Ltd., 2002) has gone furthest, with 714 descendants of its own.
- 5 other devices also cite its predicate K974521.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982816: 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/K982816
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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