Cleared Traditional

Microwave Therapeutic System (K201262) - FDA 510(k) Clearance

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

K201262 · Nanjing Eco Microwave System Co., Ltd. · General & Plastic Surgery device
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Jul 2021
Decision
424d
Days
Class 2
Risk

K201262 is an FDA 510(k) clearance for the Microwave Therapeutic System. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Nanjing Eco Microwave System Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on July 9, 2021 after a review of 424 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Nanjing Eco Microwave System Co., Ltd. devices

Submission Details

510(k) Number K201262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2020
Decision Date July 09, 2021
Days to Decision 424 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
309d slower than avg
Panel avg: 115d · This submission: 424d
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 K201262.
NEUWAVE Microwave Ablation System and Accessories
K220472 · Neuwave Medical, Inc. · Aug 2022
Solero Microwave Tissue Ablation (MTA) System and Accessories
K213067 · AngioDynamics, Inc. · Dec 2021
Disposable Microwave Therapeutic Antennas
K201265 · Nanjing Eco Microwave System Co., Ltd. · Jul 2021
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