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 ID: K052003
• 510k Number: K052003
• 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)
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: VNUS MEDICAL TECHNOLOGIES, INC. 750 CHESAPEAKE DR. Redwood City, CA 94063
• Contact: Sam Nanavati
• Correspondent: Sam Nanavati; VNUS MEDICAL TECHNOLOGIES, INC. 750 CHESAPEAKE DR. Redwood City, CA 94063
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-25
• Decision Date: 2005-10-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169862999	K052003	000
10884521058095	K052003	000
00763000723293	K052003	000