510(k) Report

FDA applicant

Vnus Medical Technologies, Inc.

Redwood City, CA9 decisions1998–20082 recalls

FDA records 9 decisions for Vnus Medical Technologies, Inc. (Redwood City, CA) from 1998 to 2008: 9 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 22 predicates, 14 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Vnus Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Vnus Medical Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories9decisions

Whose devices does it build on?

Its devices cite 22 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 19997cite it
  • K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 19986cite it
  • K003092Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 20006cite it
  • K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc. · 20066cite it
  • K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 20045cite it
  • K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 20034cite it

What has FDA decided for it lately?

  • 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
  • K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
  • K003092Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2000
  • K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999

All 9 as Vnus Medical Technologies, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K061373VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by…Aug 8, 2007
  • K061373VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc.…Mar 6, 2007