Cleared Traditional

K022856 - BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR

K022856 is an FDA 510(k) clearance for BOVIE IDS-300 HIGH FREQUENCY ELECTROSUR..., manufactured by Aaron Medical Industries. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K022856 · Aaron Medical Industries · General & Plastic Surgery device
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Feb 2003
Decision
167d
Days
Class 2
Risk

K022856 is an FDA 510(k) clearance for the BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on February 10, 2003 after a review of 167 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 Aaron Medical Industries devices

FDA 510(k) Submission Details - K022856

510(k) Number K022856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2002
Decision Date February 10, 2003
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
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 1767
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K022856.
SENORX ES-300
K030473 · Senorx, Inc. · Feb 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · Karl Storz Endoscopy · Feb 2003
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
K021852 · Olympus Optical Co., Ltd. · Feb 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · Arthrocare Corp. · Feb 2003
THERMACOOL TC SYSTEM
K030142 · Thermage, Inc. · Feb 2003
BIPOLAR FORCEPS
K023813 · Richard Wolf Medical Instruments Corp. · Jan 2003