Cleared Traditional

K892502 - ELECTROSURGICAL PENCIL

K892502 is an FDA 510(k) clearance for ELECTROSURGICAL PENCIL, manufactured by Yuntek International, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K892502 · Yuntek International, Inc. · General & Plastic Surgery device
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May 1989
Decision
34d
Days
Class 2
Risk

K892502 is an FDA 510(k) clearance for the 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 Yuntek International, Inc. (Hayward, US). The FDA issued a Cleared decision on May 15, 1989 after a review of 34 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 Yuntek International, Inc. devices

FDA 510(k) Submission Details - K892502

510(k) Number K892502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date May 15, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
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 1996
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K892502.
B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)
K894602 · Beacon Laboratories, Inc. · Aug 1989
ELECTROSURGERY ANALYZER RF302
K893659 · Bio-Tek Instruments, Inc. · Jul 1989
ASPEN DISPOSABLE BIPOLAR CORD
K893732 · Conmedcorp · Jul 1989
MALIS BIPOLAR CORD/IRRIGATION TUBING SET
K890648 · Valley Forge Scientific Corp. · Mar 1989
ADDITIONAL ELECTROSURGICAL GROUND PADS
K885172 · Conmedcorp · Jan 1989
BOVAC SMOKE COLLECTOR
K884641 · Orthopedic Systems, Inc. · Dec 1988