510(k) Report

510(k) · Cleared

Cleared

Vnus Closure System

K974521510(k) TraditionalCleared Feb 20, 199880-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vnus Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 20, 1998 as substantially equivalent to K971532 (Arthrocare Corp., 1997) and 6 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1995. 977 later devices descend from it.

Decided
Feb 20, 1998
Review
80 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K943450 (1995). 19 ancestors in all, the oldest K800617 (1980). 977 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 6 other ancestors1996: 4 other ancestors1995: 2 other ancestors1985: 1 other ancestor1980: 1 other ancestor2007: 12 descendants cleared2003: 9 descendants cleared2002: 4 descendants cleared1999: 1 descendant cleared2006: 8 descendants cleared2004: 6 descendants cleared2005: 12 descendants cleared2008: 26 descendants cleared2016: 50 descendants cleared2014: 37 descendants cleared2024: 92 descendants cleared2023: 66 descendants cleared2018: 48 descendants cleared2010: 27 descendants cleared2025: 131 descendants cleared2009: 20 descendants cleared2021: 47 descendants cleared2012: 19 descendants cleared2020: 47 descendants cleared2015: 36 descendants cleared2011: 20 descendants cleared2013: 26 descendants cleared2017: 52 descendants cleared2019: 35 descendants cleared2026: 76 descendants cleared2022: 70 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 29 descendants4 generations forward: 61 descendants5 generations forward: 117 descendants6 generations forward: 163 descendants7 generations forward: 154 descendants8 generations forward: 152 descendants9 generations forward: 120 descendants10 generations forward: 83 descendants11 generations forward: 48 descendants12 generations forward: 14 descendants13 generations forward: 11 descendants14 generations forward: 2 descendants15 generations forward: 5 descendants16 generations forward: 1 descendant K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−50+5+10+15
  1. Root · 5 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 4 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 3 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 2 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 1 generation backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. This deviceK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. Descendant · cites it directly · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. Descendant · cites it directly · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
  9. Descendant · 2 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002
  10. Descendant · 2 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
  11. Descendant · 3 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003

Showing 5 of 977 descendants. See all descendants

Descendants cleared per year

1999: 12002: 42003: 92004: 62005: 122006: 82007: 122008: 262009: 202010: 272011: 202012: 192013: 262014: 372015: 362016: 502017: 522018: 482019: 352020: 472021: 472022: 702023: 662024: 922025: 1312026: 76
1999high 131 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 977 · See all
  • K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · cites it directly973descendants
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · cites it directly714descendants
  • K022266Aurora SRSyneron Medical, Ltd. · 2002 · 2 generations on705descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−4K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−3K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−2K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−1K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
0 (this device)K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
+1K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
+1K012398Diomed 15 Diode LaserDiomed, Ltd.2002—
+2K022266Aurora SRSyneron Medical, Ltd.2002—
+2K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D…Dornier Medtech America, Inc.2002—
+3K030186Polris LVSyneron Medical, Ltd.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199520
199640
199760

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200240
200390
200460
2005120
200680
2007120
2008260
2009200
2010270
2011200
2012190
2013260
2014370
2015360
2016500
2017520
2018480
2019350
2020470
2021470
2022700
2023660
2024920
20251310
2026760
FIG. 1 — Lineage of K974521, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K971532Arthrocare Electrosurgery System
Summary page 1
…ial Equivalence FEB 20 1908 VNUS Closure™ System B. Common Name Electrosurgery System/Electrosurgical Coagulator C. Predicate Device(s) ArthroCare Electrosurgery System (K971532) Boston Surgical Products, Inc. Model 50 Bipolar Coagulator (K972350) Somnus Model 215 Electrosurgical Generator and Accessories…
Arthrocare Corp.1997—
*K972350Model 50 Bipolar Coagulator
Summary page 1
…rosurgery System/Electrosurgical Coagulator C. Predicate Device(s) ArthroCare Electrosurgery System (K971532) Boston Surgical Products, Inc. Model 50 Bipolar Coagulator (K972350) Somnus Model 215 Electrosurgical Generator and Accessories (K971711) Valley Forge Scientific Mini-Symm Bipolar Coagulator (K9641…
Boston Surgical Products, Inc.1997—
*K971711Somnus Model 215 Electrosurgical Generator
Summary page 1
…throCare Electrosurgery System (K971532) Boston Surgical Products, Inc. Model 50 Bipolar Coagulator (K972350) Somnus Model 215 Electrosurgical Generator and Accessories (K971711) Valley Forge Scientific Mini-Symm Bipolar Coagulator (K964143) Bergen Model 500 Electrosurgery Generator (K972299) Bergen 610 Co…
Somnus Medical Technologies, Inc.1997—
*K964143Mini-Symm Bipolar Coagulator
Summary page 1
…ts, Inc. Model 50 Bipolar Coagulator (K972350) Somnus Model 215 Electrosurgical Generator and Accessories (K971711) Valley Forge Scientific Mini-Symm Bipolar Coagulator (K964143) Bergen Model 500 Electrosurgery Generator (K972299) Bergen 610 Coagulator (K964736) Kirwan 28 1000 Coagulator (K971341) D. Devic…
Valley Forge Scientific Corp.1997—
*K972299Bergen Model 500 Electrosurgery Generator
Summary page 1
…s Model 215 Electrosurgical Generator and Accessories (K971711) Valley Forge Scientific Mini-Symm Bipolar Coagulator (K964143) Bergen Model 500 Electrosurgery Generator (K972299) Bergen 610 Coagulator (K964736) Kirwan 28 1000 Coagulator (K971341) D. Device Description The VNUS Closure™ System consists of t…
Bergen Mfg.1997—
*K964736Bergen 610 Bipolar Coagulator
Summary page 1
…rator and Accessories (K971711) Valley Forge Scientific Mini-Symm Bipolar Coagulator (K964143) Bergen Model 500 Electrosurgery Generator (K972299) Bergen 610 Coagulator (K964736) Kirwan 28 1000 Coagulator (K971341) D. Device Description The VNUS Closure™ System consists of three main components: The VNUS C…
Bergen Mfg.1997—
*K971341Kirwan Model 28 1000 Bipolar Coagulator
Summary page 1
…ey Forge Scientific Mini-Symm Bipolar Coagulator (K964143) Bergen Model 500 Electrosurgery Generator (K972299) Bergen 610 Coagulator (K964736) Kirwan 28 1000 Coagulator (K971341) D. Device Description The VNUS Closure™ System consists of three main components: The VNUS Closure Probe, the VNUS RF Generator…
Kirwan Surgical Products, Inc.1997—

Also cleared against K971532: 6 other devices →

What descends from it? (977)

See all 977

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999973
K012398Diomed 15 Diode LaserDiomed, Ltd.2002714
K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.20032
K072126Habib VesealEmcision, Ltd.20070
K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060
K014251Ntero Hotrod SystemNtero Surgical, Inc.20020

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 3 years and passes through 2 companies; a new generation was cleared every 7 months on median.
  • 1 of the 19 ancestors has a recall of any class.
  • Of its descendants, K982816 (Vnus Medical Technologies, Inc., 1999) has gone furthest, with 973 descendants of its own.
  • 6 other devices also cite its predicate K971532.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The VNUS Closure™ System is indicated for use in the coagulation of blood vessels during general surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K971532

6 other devices cite the same predicate.

  • K062539Ncontact Coagulation System KitNcontact Surgical, Inc. · 2006
  • K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
  • K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002
  • K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001
  • K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
  • K992972Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Electrosurgery Wand…Arthrocare Corp. · 1999

More from Vnus Medical Technologies, Inc.

9 FDA decisions under this applicant name. See the company

  • K082890Vnus Closurefast Intravascular Catheter, Models CF7-7-60-2, CF7-7-100-2Vnus Medical Technologies, Inc. · 2008
  • K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc. · 20062 recalls
  • K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40)Vnus Medical Technologies, Inc. · 2005
  • K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
  • K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K974521 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974521: Vnus Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974521

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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