Cleared Special

K102913 - FORCETRIAD

K102913 is an FDA 510(k) clearance for FORCETRIAD, manufactured by Covidien, Formerly Valleylab, A Division of Tyco H. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 217-day FDA review.

K102913 · Covidien, Formerly Valleylab, A Division of Tyco H · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
217d
Days
Class 2
Risk

K102913 is an FDA 510(k) clearance for the FORCETRIAD. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Covidien, Formerly Valleylab, A Division of Tyco H (Boulder, US). The FDA issued a Cleared decision on May 6, 2011 after a review of 217 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102913

510(k) Number K102913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date May 06, 2011
Days to Decision 217 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 115d · This submission: 217d
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 2168
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K102913.
HET BIPOLAR ELECTROCAUTERY FORCEPS
K110143 · Het Systems, LLC · Jun 2011
FORCETRIAD ELECTROSURGICAL GENERATOR
K110268 · Covidien Lp, Formerly Know AS Valleylab, A Divison · May 2011
PEAK SUCTION COAGULATOR
K103775 · Peak Surgical, Inc. · May 2011
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
K100669 · Us Medical Innovations, LLC · Apr 2011
AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
K101057 · Salient Surgical Technologies · Apr 2011
THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
K102275 · Thermedx, LLC · Mar 2011