Cleared Special

K160936 - Certus 140 2.45GHz Ablation System

K160936 is an FDA 510(k) clearance for Certus 140 2.45GHz Ablation System, manufactured by Neuwave Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Special 510(k) pathway after a 30-day FDA review.

K160936 · Neuwave Medical, Inc. · General & Plastic Surgery device
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May 2016
Decision
30d
Days
Class 2
Risk

K160936 is an FDA 510(k) clearance for the Certus 140 2.45GHz Ablation System. 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 May 4, 2016 after a review of 30 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 Neuwave Medical, Inc. devices

FDA 510(k) Submission Details - K160936

510(k) Number K160936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2016
Decision Date May 04, 2016
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 40
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K160936.
miraDry System
K180396 · Miramar Labs, Inc. · Mar 2018
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
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EMPRINT ABLATION SYSTEM
K133821 · Covidien, LLC · Apr 2014
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · Guidant Corp. · Jul 2006