Cleared Traditional

K012279 - PATTON TRIPOL

K012279 is an FDA 510(k) clearance for PATTON TRIPOL, manufactured by Patton Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K012279 · Patton Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
285d
Days
Class 2
Risk

K012279 is an FDA 510(k) clearance for the PATTON TRIPOL. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Patton Medical Corp. (Austin, US). The FDA issued a Cleared decision on April 30, 2002 after a review of 285 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 Patton Medical Corp. devices

FDA 510(k) Submission Details - K012279

510(k) Number K012279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2001
Decision Date April 30, 2002
Days to Decision 285 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 115d · This submission: 285d
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 1514
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K012279.
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