Cleared Traditional

ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE (K940909) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940909 · Debusk Technology Corp. · General & Plastic Surgery device
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Mar 1994
Decision
35d
Days
Class 2
Risk

K940909 is an FDA 510(k) clearance for the ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE. 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 March 30, 1994 after a review of 35 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 Debusk Technology Corp. devices

Submission Details

510(k) Number K940909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date March 30, 1994
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 570
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K940909.
KARL STORZ INSULATED SCISSORS AND RECTAL SNARES
K944530 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION
K936036 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
AESCULAP ENDOSCOPIC INSTRUMENTS
K940936 · Aesculap, Inc. · Apr 1994
ENDOPATH ENDOSCOPIC ELECTROSURGICAL FORCEPS WITH CUTTING FEATURE
K934784 · Ethicon, Inc. · Mar 1994
ELECTROSURGIAL INSTRUMENTS
K932654 · Medline Industries, Inc. · Feb 1994
ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
K934985 · KARL STORZ Endoscopy-America, Inc. · Feb 1994