Cleared Traditional

K946104 - SMOKIEVAC ELECTROSURGICAL PENCIL

K946104 is an FDA 510(k) clearance for SMOKIEVAC ELECTROSURGICAL PENCIL, manufactured by Aspen Laboratories, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K946104 · Aspen Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
110d
Days
Class 2
Risk

K946104 is an FDA 510(k) clearance for the SMOKIEVAC ELECTROSURGICAL PENCIL. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Aspen Laboratories, Inc. (Centennial, US). The FDA issued a Cleared decision on April 3, 1995 after a review of 110 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 Aspen Laboratories, Inc. devices

FDA 510(k) Submission Details - K946104

510(k) Number K946104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date April 03, 1995
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
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 1260
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K946104.
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950406 · Aaron Medical Industries · Apr 1995
BIPOLAR FORCEPS
K951035 · Megadyne Medical Products, Inc. · Apr 1995
FINESS I (DERMATOLOGIC APPLICATION)
K951032 · Utah Medical Products, Inc. · Apr 1995
KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE
K950953 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
VALLEYLAB COATED ELECTRODES
K950188 · Valleylab, Inc. · Feb 1995
HIGH TEMPERATURE CAUTERY
K945492 · Aaron Medical Industries · Jan 1995