Cleared Traditional

K854231 - ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES

K854231 is an FDA 510(k) clearance for ELECTROSURGICAL CUTTING & COAGULATION D..., manufactured by Clinical 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 193-day FDA review.

K854231 · Clinical Technology Corp. · General & Plastic Surgery device
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May 1986
Decision
193d
Days
Class 2
Risk

K854231 is an FDA 510(k) clearance for the ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Clinical Technology Corp. (Rochester, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 193 days - an extended review 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: 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 Clinical Technology Corp. devices

FDA 510(k) Submission Details - K854231

510(k) Number K854231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date May 02, 1986
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 1846
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K854231.
ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)
K861139 · Conmedcorp · May 1986
PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD
K855084 · Conmedcorp · May 1986
E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
K861036 · Valleylab, Inc. · May 1986
BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768
K860687 · Birtcher Corp. · Mar 1986
ELECTROSURGERY PENCIL, MODEL 767
K860718 · Birtcher Corp. · Mar 1986
SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33
K854814 · Birtcher Corp. · Jan 1986