Cleared Traditional

Microwave Ablation System (K183153) - FDA 510(k) Clearance

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

K183153 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · General & Plastic Surgery device
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Jul 2019
Decision
236d
Days
Class 2
Risk

K183153 is an FDA 510(k) clearance for the Microwave Ablation System. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on July 8, 2019 after a review of 236 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 Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. devices

Submission Details

510(k) Number K183153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2018
Decision Date July 08, 2019
Days to Decision 236 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
121d slower than avg
Panel avg: 115d · This submission: 236d
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 K183153.
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
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
K193232 · Covidien, LLC · Feb 2020
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
K182250 · AngioDynamics, Inc. · Feb 2019
Certus 140 2.45GHz Ablation System
K173756 · Neuwave Medical, Inc. · Oct 2018
Swift System
K181941 · Emblation , Ltd. · Oct 2018