Cleared Traditional

K021079 - ABCSNARE ELECTROSURGICAL PROBE FOR FLEX...

K021079 is an FDA 510(k) clearance for ABCSNARE ELECTROSURGICAL PROBE FOR FLEX..., manufactured by Conmedcorp. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K021079 · Conmedcorp · General & Plastic Surgery device
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Jul 2002
Decision
89d
Days
Class 2
Risk

K021079 is an FDA 510(k) clearance for the ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmedcorp (Centennial, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 89 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 Conmedcorp devices

FDA 510(k) Submission Details - K021079

510(k) Number K021079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2002
Decision Date July 01, 2002
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 1271
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K021079.
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
K021777 · Gyrus Ent LLC · Aug 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · Boston Scientific Corp · Jul 2002
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
K021817 · Aaron Medical Industries · Jul 2002
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
K021299 · Conmedcorp · Jun 2002
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K021519 · Arthrocare Corp. · Jun 2002
WALLACH LOOP ELECTRODE
K020711 · Wallach Surgical Devices, Inc. · Jun 2002