Cleared Special

K032062 - STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)

K032062 is an FDA 510(k) clearance for STELLARTECH COAGULATION SYSTEM, manufactured by Stellartech Research Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 26-day FDA review.

K032062 · Stellartech Research Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
26d
Days
Class 2
Risk

K032062 is an FDA 510(k) clearance for the STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Stellartech Research Corp. (Sunnyvale, US). The FDA issued a Cleared decision on July 29, 2003 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stellartech Research Corp. devices

FDA 510(k) Submission Details - K032062

510(k) Number K032062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2003
Decision Date July 29, 2003
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 1529
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K032062.
ARTHROCARE SYSTEM
K032504 · Arthrocare Corp. · Aug 2003
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K032207 · Boston Scientific Corp · Aug 2003
MODIFICATION TO THERMACOOL TC SYSTEM
K032088 · Thermage, Inc. · Aug 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
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CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
K031247 · Medtronic Vascular · Jul 2003
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
K031950 · Baylis Medical Co., Inc. · Jul 2003