FDA 510(k)

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

K-Number: K052003 · 2005-10-11

ApplicantVnus Medical Technologies, Inc.

Decision Date2005-10-11

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) is the device name listed in this FDA 510(k) record. The listed applicant is Vnus Medical Technologies, Inc.. It received FDA 510(k) clearance on 2005-10-11 under 510(k) number K052003. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)?

VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) is a medical device that received FDA 510(k) clearance on 2005-10-11. The listed applicant is Vnus Medical Technologies, Inc.. The 510(k) number is K052003.

When did VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) receive FDA 510(k) clearance?

VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) received FDA 510(k) clearance on 2005-10-11, under 510(k) number K052003.

Who is the listed applicant for VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)?

The FDA 510(k) record lists Vnus Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)?

The FDA product code for VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) is GEI.

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Other records listing Vnus Medical Technologies, Inc. as applicant

K082890VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 K061373VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 K040638VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 K033547VNUS VESSEL AND TISSUE COAGULATION SYSTEM K030557MODIFICATION TO VNUS CLOSURE SYSTEM K003092MODIFICATION TO VNUS CLOSURE SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.