Cleared Special

K021117 - TTI THERMOMED MODEL 1.8 INSTRUMENT

K021117 is an FDA 510(k) clearance for TTI THERMOMED MODEL 1.8 INSTRUMENT, manufactured by Thermosurgery Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 24-day FDA review.

K021117 · Thermosurgery Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
24d
Days
Class 2
Risk

K021117 is an FDA 510(k) clearance for the TTI THERMOMED MODEL 1.8 INSTRUMENT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Thermosurgery Technologies, Inc. (Phoenix, US). The FDA issued a Cleared decision on May 2, 2002 after a review of 24 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 Thermosurgery Technologies, Inc. devices

FDA 510(k) Submission Details - K021117

510(k) Number K021117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2002
Decision Date May 02, 2002
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 1593
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K021117.
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
K020778 · Gyrus Ent LLC · May 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
K020579 · Aaron Medical Industries · May 2002
SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF
K020408 · Arthrocare Corp. · May 2002
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
K020919 · AtriCure, Inc. · Apr 2002
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
K021077 · Megadyne Medical Products, Inc. · Apr 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · Boston Scientific Corp · Apr 2002