VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)— 510(k) K052003

Substantially Equivalent

Vnus Medical Technologies, Inc.

FDA 510(k) clearance K052003 for VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40), Substantially Equivalent on 2005-10-11. Applicant: Vnus Medical Technologies, Inc..

Clearance details

Applicant: Vnus Medical Technologies, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2005-07-25
Decision date: 2005-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.