Cleared Traditional

K992045 - ELECTROSURGICAL ELECTRODE FAMILY

K992045 is an FDA 510(k) clearance for ELECTROSURGICAL ELECTRODE FAMILY, manufactured by Genesis Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K992045 · Genesis Medical, Inc. · General & Plastic Surgery device
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Jan 2000
Decision
224d
Days
Class 2
Risk

K992045 is an FDA 510(k) clearance for the ELECTROSURGICAL ELECTRODE FAMILY. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Genesis Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 224 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 Genesis Medical, Inc. devices

FDA 510(k) Submission Details - K992045

510(k) Number K992045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1999
Decision Date January 27, 2000
Days to Decision 224 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 115d · This submission: 224d
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 1528
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K992045.
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
K000074 · Arthrocare Corp. · Feb 2000
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
K992805 · Oratec Interventions, Inc. · Feb 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
K000044 · Arthrocare Corp. · Feb 2000
STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230
K994173 · Stellartech Research Corp. · Jan 2000
ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
K994333 · Oratec Interventions, Inc. · Jan 2000
GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
K994075 · Geiger Medical Technologies, Inc. · Dec 1999