Cleared Traditional

Microwave Ablation Device (Exceed S10U) (K233140) - FDA 510(k) Clearance

Also marketed or referenced as:
Sterile Microwave Ablation Probe (Exact)

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

K233140 · Hygea Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
126d
Days
Class 2
Risk

K233140 is an FDA 510(k) clearance for the Microwave Ablation Device (Exceed S10U). Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Hygea Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 31, 2024 after a review of 126 days - within the typical 510(k) review window.

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 Hygea Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K233140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date January 31, 2024
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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 K233140.
Temperature Sensor Probe (ABL-18TP20)
K240784 · Varian Medical Systems, Inc. · May 2024
swiftPro™ System
K240518 · Emblation Limited · Apr 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · Medtronic, Inc. · Mar 2024
NEUWAVE™ Microwave Ablation System and Accessories
K231738 · Neuwave Medical, Inc. · Nov 2023
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