Cleared Traditional

NEUWAVE™ Microwave Ablation System and Accessories (K231738) - FDA 510(k) Clearance

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

K231738 · Neuwave Medical, Inc. · General & Plastic Surgery device
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Nov 2023
Decision
155d
Days
Class 2
Risk

K231738 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 16, 2023 after a review of 155 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 Neuwave Medical, Inc. devices

Submission Details

510(k) Number K231738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2023
Decision Date November 16, 2023
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 K231738.
swiftPro™ System
K240518 · Emblation Limited · Apr 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · Medtronic, Inc. · Mar 2024
Microwave Ablation Device (Exceed S10U)
K233140 · Hygea Medical Technology Co., Ltd. · Jan 2024
Microwave Ablation System (BD-GT)
K232240 · Betters(Suzhou) Medical Co., Ltd. · Nov 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
K232241 · Betters(Suzhou) Medical Co., Ltd. · Nov 2023
AB1 Electrosurgical Instrument, Creo Electrosurgical System
K223138 · Creo Medical, Ltd. · Jun 2023