Cleared Traditional

NEUWAVE Microwave Ablation System and Accessories (K200081) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200081 · Neuwave Medical, Inc. · General & Plastic Surgery device
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Nov 2020
Decision
303d
Days
Class 2
Risk

K200081 is an FDA 510(k) clearance for the NEUWAVE 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 November 13, 2020 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K200081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2020
Decision Date November 13, 2020
Days to Decision 303 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
188d slower than avg
Panel avg: 115d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K200081.
ABI Instrument, Creo Electrosurgical System
K200298 · Creo Medical, Ltd. · Jan 2021
Emprint SX Ablation Platform with Thermosphere Technology
K203303 · Covidien, LLC · Dec 2020
AveCure BT Microwave Ablation System
K192406 · Medwaves, Inc. · Nov 2020
NP1 Instrument, Creo Electrosurgical System
K200003 · Creo Medical, Ltd. · Oct 2020
Emprint Ablation System with Thermosphere Technology
K200796 · Covidien, LLC · Aug 2020
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
K200061 · Galil Medical, Inc. · Jul 2020