510(k) Report

510(k) · Cleared

Cleared

Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40)

K052003510(k) TraditionalCleared Oct 11, 200578-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 Oct 11, 2005 as substantially equivalent to K982816 (Vnus Medical Technologies, Inc., 1999) and 3 other predicates after a 78-day review. Its family tree reaches back 9 generations to 1995. 5 later devices descend from it.

Decided
Oct 11, 2005
Review
78 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K943450 (1995). 31 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1997: 6 other ancestors1996: 4 other ancestors1995: 3 other ancestors1994: 1 other ancestor1992: 2 other ancestors1985: 1 other ancestor1980: 1 other ancestor2018: 2 descendants cleared2021: 1 descendant cleared2025: 2 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) K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K030557 · Modification to Vnus Closure System · Vnus Medical Technologies, Inc. · 2003K033547 · Vnus Vessel and Tissue Coagulation System · Vnus Medical Technologies, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 9 other ancestors4 generations back: 10 other ancestors5 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K033547 · Vnus Vessel and Tissue Coagulation System · Vnus Medical Technologies, Inc. · 2004K030557 · Modification to Vnus Closure System · Vnus Medical Technologies, Inc. · 2003K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K971532 · 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
  1. Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 5 generations between
  3. 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  4. 2 generations backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
  5. 1 generation backK033547 Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004
  6. This deviceK052003 Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex…Vnus Medical Technologies, Inc. · 2005
  7. Descendant · cites it directly · 2 of its ownK211806 Venclose digiRF Generator with Maven Catheter, Venclose Maven…Venclose, Inc. · 2021 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK250068 Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · Recalled
  9. Descendant · 3 generations on · 0 of its ownK252316 Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter…Venclose, Inc. · 2025
  10. Descendant · cites it directly · 0 of its ownK181044 400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc. · 2018
  11. Descendant · cites it directly · 0 of its ownK173214 NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes) · 2018
Show all 9 generations
  1. Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. 2 generations backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
  9. 1 generation backK033547 Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004
  10. This deviceK052003 Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex…Vnus Medical Technologies, Inc. · 2005

Most influential descendants

Showing 5 of 5 · See all
  • K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc. · 2021 · cites it directly2descendants
  • K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · 2 generations on1descendant
  • K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc. · 2025 · 3 generations on0descendants
  • K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc. · 2018 · cites it directly0descendants
  • K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes) · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−8K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−7K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−6K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−5K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−4K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
−3K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
−2K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc.2003—
−1K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.2004—
0 (this device)K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model…Vnus Medical Technologies, Inc.2005—
+1K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose…Venclose, Inc.20211
+2K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.20251
+3K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60…Venclose, Inc.2025—
+1K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.2018—
+1K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199220
199410
199530
199640
199760
199820
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
202110
202520
FIG. 1 — Lineage of K052003, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (4)

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
*K982816Vnus Closure System
Summary page 1
…tantial Equivalence VNUS RFS and RFSF/ex devices B. Common Name Bipolar Electrosurgical Instrument C. Predicate Device(s) VNUIS® Closure® System (K982816, K003092, and K030557); and VNUJS® Vessel and Tissue Coagulation System (proprietary name: TBD) (K033547) 0. Device Des…
Vnus Medical Technologies, Inc.1999—
*K003092Modification to Vnus Closure System
Summary page 1
…quivalence VNUS RFS and RFSF/ex devices B. Common Name Bipolar Electrosurgical Instrument C. Predicate Device(s) VNUIS® Closure® System (K982816, K003092, and K030557); and VNUJS® Vessel and Tissue Coagulation System (proprietary name: TBD) (K033547) 0. Device Description…
Vnus Medical Technologies, Inc.2000—
*K030557Modification to Vnus Closure System
Summary page 1
…VNUS RFS and RFSF/ex devices B. Common Name Bipolar Electrosurgical Instrument C. Predicate Device(s) VNUIS® Closure® System (K982816, K003092, and K030557); and VNUJS® Vessel and Tissue Coagulation System (proprietary name: TBD) (K033547) 0. Device Description The VNU…
Vnus Medical Technologies, Inc.2003—
*K033547Vnus Vessel and Tissue Coagulation System
Summary page 1
…nt C. Predicate Device(s) VNUIS® Closure® System (K982816, K003092, and K030557); and VNUJS® Vessel and Tissue Coagulation System (proprietary name: TBD) (K033547) 0. Device Description The VNULS RFS family of devices is a bipolar, high frequency electrosurgical system design…
Vnus Medical Technologies, Inc.2004—

Also cleared against K982816: 6 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.20212
K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180
K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180

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 10 years and passes through 2 companies; a new generation was cleared every 10 months on median.
  • 1 of the 31 ancestors has a recall of any class.
  • Of its descendants, K211806 (Venclose, Inc., 2021) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K982816.

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 RFS and RFSFlex devices are intended for use in vessel and tissue coagulation including:

Treatment of incompetent (i.e., refluxing) perforator and tributary veins

Indications for use as stated in the FDA summary.

Also cleared against K982816

6 other devices cite the same predicate.

  • K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
  • K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004
  • K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
  • K023624SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921Surgical Laser Technologies, Inc. · 2003
  • K022266Aurora SRSyneron Medical, Ltd. · 2002
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002

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
  • K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
  • K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004
  • K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003

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/K052003 · printed Nov 3, 2026

Cite this page

510(k) Report. “K052003: Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052003

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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