Cleared Traditional

K093025 - BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES

K093025 is an FDA 510(k) clearance for BOVIE RESISTICK II COATED ELECTROSURGIC..., manufactured by Bovie Medical Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K093025 · Bovie Medical Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
84d
Days
Class 2
Risk

K093025 is an FDA 510(k) clearance for the BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES. 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 December 22, 2009 after a review of 84 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.

View all Bovie Medical Corporation devices

FDA 510(k) Submission Details - K093025

510(k) Number K093025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date December 22, 2009
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 1753
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K093025.
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · Ethicon Endo-Surgery, Inc. · Jan 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · Arthrocare Corp. · Jan 2010
MATRIX RF APPLICATOR
K090025 · Syneron Medical, Ltd. · Jan 2010
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
K093165 · Arthrocare Corp. · Dec 2009
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
K091824 · Ethicon Endo-Surgery, Inc. · Nov 2009
PROPENCIL ESU PENCIL
K092732 · Bio Protech, Inc. · Nov 2009