Cleared Special

K030557 - MODIFICATION TO VNUS CLOSURE SYSTEM

K030557 is an FDA 510(k) clearance for MODIFICATION TO VNUS CLOSURE SYSTEM, manufactured by Vnus Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 18-day FDA review.

K030557 · Vnus Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
18d
Days
Class 2
Risk

K030557 is an FDA 510(k) clearance for the MODIFICATION TO VNUS CLOSURE SYSTEM. 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 March 11, 2003 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vnus Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K030557

510(k) Number K030557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2003
Decision Date March 11, 2003
Days to Decision 18 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 1485
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K030557.
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
K030362 · Leonhard Lang GmbH · Apr 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · Radionics, Inc. · Apr 2003
HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
K024138 · Olympus Optical Co., Ltd. · Mar 2003
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K030551 · Arthrocare Corp. · Mar 2003
SENORX ES-300
K030473 · Senorx, Inc. · Feb 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · Karl Storz Endoscopy · Feb 2003