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

Electrosurgical, Cutting & Coagulation & Accessories

VNUS MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Vnus Medical Technologies, Inc. with the FDA for Vnus Rfs, Model Rfs-6-xx (xx = 10, 12, 13, & 15); Vnus Rfs Flex, Model Rfx-6-xx (xx = 10, 20, 30 & 40).

Pre-market Notification Details

Device IDK052003
510k NumberK052003
Device Name:VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VNUS MEDICAL TECHNOLOGIES, INC. 750 CHESAPEAKE DR. Redwood City,  CA  94063
ContactSam Nanavati
CorrespondentSam Nanavati
VNUS MEDICAL TECHNOLOGIES, INC. 750 CHESAPEAKE DR. Redwood City,  CA  94063
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-25
Decision Date2005-10-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169862999 K052003 000
10884521058095 K052003 000
00763000723293 K052003 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.