Cleared Traditional

K896626 - HAND CONTROLLED ELECTROSURGICAL PENCILS

K896626 is an FDA 510(k) clearance for HAND CONTROLLED ELECTROSURGICAL PENCILS, 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 51-day FDA review.

K896626 · Conmedcorp · General & Plastic Surgery device
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Jan 1990
Decision
51d
Days
Class 2
Risk

K896626 is an FDA 510(k) clearance for the HAND CONTROLLED ELECTROSURGICAL PENCILS. 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 (Utica, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 51 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 - K896626

510(k) Number K896626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date January 11, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
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 K896626.
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
K900332 · 3M Company · Feb 1990
MF-450 ELECTROSURGICAL UNIT 60-5500-001
K896839 · Aspen Laboratories, Inc. · Feb 1990
MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III
K896541 · Valley Forge Scientific Corp. · Jan 1990
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