Cleared Traditional

K143203 - AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe

K143203 is an FDA 510(k) clearance for AveCure Microwave Coagulation-Ablation ..., manufactured by Medwaves Incorporated. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K143203 · Medwaves Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
292d
Days
Class 2
Risk

K143203 is an FDA 510(k) clearance for the AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Ant.... Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Medwaves Incorporated (San Diego, US). The FDA issued a Cleared decision on August 26, 2015 after a review of 292 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.

FDA 510(k) Submission Details - K143203

510(k) Number K143203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2014
Decision Date August 26, 2015
Days to Decision 292 days
Submission Type Traditional
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
177d slower than avg
Panel avg: 115d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEY Device Classification - Class 2, Special Controls

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - NEY System, Ablation, Microwave And Accessories

All 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K143203.
Emprint Ablation System
K163105 · Covidien, LLC · Dec 2016
miraDry System
K160141 · Miramar Labs, Inc. · Oct 2016
Certus 140 2.45GHz Ablation System
K160936 · Neuwave Medical, Inc. · May 2016
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K141785 · Bsd Medical Corp. · Mar 2015
EMPRINT ABLATION SYSTEM
K133821 · Covidien, LLC · Apr 2014
CERTUS 140 CERTUSURGGT SURGICAL TOOL
K130399 · Neuwave Medical, Inc. · Jul 2013
K143203 · AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
Download PDF FDA Summary Medwaves Incorporated