Cleared Traditional

K081431 - MEG LAPAROSCOPIC ELECTRODES

K081431 is an FDA 510(k) clearance for MEG LAPAROSCOPIC ELECTRODES, manufactured by Bovie Medical. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K081431 · Bovie Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
64d
Days
Class 2
Risk

K081431 is an FDA 510(k) clearance for the MEG LAPAROSCOPIC 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 (St. Petersburg, US). The FDA issued a Cleared decision on July 24, 2008 after a review of 64 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 devices

FDA 510(k) Submission Details - K081431

510(k) Number K081431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2008
Decision Date July 24, 2008
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 1488
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K081431.
ARTHROCARE ARTHROWANDS
K082323 · Arthrocare Corp. · Aug 2008
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003
K082054 · Gyrus Acmi, Inc. · Aug 2008
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
K081954 · Gyrus Acmi, Inc. · Jul 2008
ONCOBIONIC BIPOLAR ELECTRODE
K080287 · AngioDynamics, Inc. · Jul 2008
UNIBLATE ELECTROSURGICAL DEVICE
K080451 · AngioDynamics, Inc. · Jul 2008
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
K081634 · Conmed Corporation · Jun 2008