Cleared Traditional

K040638 - VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2

K040638 is an FDA 510(k) clearance for VNUS RADIOFREQUENCY GENERATOR, manufactured by Vnus Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K040638 · Vnus Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
89d
Days
Class 2
Risk

K040638 is an FDA 510(k) clearance for the VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Vnus Medical Technologies, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 7, 2004 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040638

510(k) Number K040638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date June 07, 2004
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2211
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K040638.
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
K030831 · Modern Medical Equipment Mfg., Ltd. · Jun 2004
MODERN MEDICAL BIPOLAR FORCEPS
K032327 · Modern Medical Equipment Mfg., Ltd. · Jun 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
K041383 · Stellartech Research Corp. · Jun 2004
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
K040699 · Megadyne Medical Products, Inc. · Jun 2004
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K041347 · Neothermia Corp. · Jun 2004
LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
K032965 · Modern Medical Equipment Mfg., Ltd. · May 2004
K040638 · VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2
Download PDF FDA Summary Vnus Medical Technolo…