Cleared Traditional

K163118 - FLEX Microwave Ablation System and Accessories

K163118 is an FDA 510(k) clearance for FLEX Microwave Ablation System and Acce..., manufactured by Neuwave Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K163118 · Neuwave Medical, Inc. · General & Plastic Surgery device
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Mar 2017
Decision
121d
Days
Class 2
Risk

K163118 is an FDA 510(k) clearance for the FLEX Microwave Ablation System and Accessories. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Neuwave Medical, Inc. (Madision, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 121 days - within the typical 510(k) review window.

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 Neuwave Medical, Inc. devices

FDA 510(k) Submission Details - K163118

510(k) Number K163118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date March 09, 2017
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
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 K163118.
miraDry System
K180396 · Miramar Labs, Inc. · Mar 2018
Emprint SX Ablation Platform and Accessories
K171358 · Coviden, LLC · Sep 2017
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
K162449 · AngioDynamics, Inc. · May 2017
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