Cleared Special

K040240 - STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

K040240 is an FDA 510(k) clearance for STELLARTECH COAGULATION SYSTEM (MODELS ..., 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 58-day FDA review.

K040240 · Stellartech Research Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
58d
Days
Class 2
Risk

K040240 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 April 1, 2004 after a review of 58 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 - K040240

510(k) Number K040240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2004
Decision Date April 01, 2004
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K040240.
THERMAGE THERMACOOL SYSTEM
K040135 · Thermage, Inc. · Jun 2004
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
K040699 · Megadyne Medical Products, Inc. · Jun 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · Boston Scientific Corp · Apr 2004
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
K040338 · Arthrocare Corp. · Mar 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · Stryker Corp. · Feb 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · Smith & Nephew, Inc. · Feb 2004