Cleared Traditional

K940299 - ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD

K940299 is an FDA 510(k) clearance for ELECTROSURGICAL DISPERSIVE ELECTRODE AN..., manufactured by Debusk Technology Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K940299 · Debusk Technology Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
101d
Days
Class 2
Risk

K940299 is an FDA 510(k) clearance for the ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTROD.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Debusk Technology Corp. (Powell, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 101 days - within the typical 510(k) review window.

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 Debusk Technology Corp. devices

FDA 510(k) Submission Details - K940299

510(k) Number K940299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date May 02, 1994
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
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 1828
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K940299.
FLOWGUN ELECTROCAUTERY PROBES
K935971 · O.R. Concepts, Inc. · May 1994
VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC
K941968 · Valleylab, Inc. · May 1994
ELMED ESU 300 M/M AND DIGITAL
K932938 · Elmed, Inc. · May 1994
TITANIUM BIPOLAR FORCEPS
K940466 · Radionics, Inc. · Apr 1994
AESCULAP ENDOSCOPIC INSTRUMENTS
K940936 · Aesculap, Inc. · Apr 1994
CONMED T.D.S. ELECTROSURGICAL GROUND PAD
K941160 · Conmedcorp · Apr 1994