Cleared Traditional

K092383 - BOVIE ICON VS GENERAL PURPOSE RF GENERATOR

K092383 is the FDA 510(k) clearance for BOVIE ICON VS GENERAL PURPOSE RF GENERATOR by Bovie Medical Corporation. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K092383 · Bovie Medical Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
217d
Days
Class 2
Risk

K092383 is an FDA 510(k) clearance for the BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Bovie Medical Corporation (Clearwater, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bovie Medical Corporation devices

Submission Details

510(k) Number K092383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date March 10, 2010
Days to Decision 217 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 115d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1119
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K092383.
CONMED MACROLYTE DISPERSIVE ELECTRODE
K100686 · Conmed Corporation · May 2010
SUREFIT DUAL DISPERSIVE ELECTRODE
K100047 · Conmed Corporation · May 2010
SPINEWAND SURGICAL DEVICE
K100353 · Arthrocare Corp. · May 2010
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
K093203 · Medtronic, Inc. · Feb 2010
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · Ethicon Endo-Surgery, Inc. · Jan 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · Arthrocare Corp. · Jan 2010