Cleared Traditional

K233140 - Microwave Ablation Device (Exceed S10U)

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

K233140 is an FDA 510(k) clearance for Microwave Ablation Device (Exceed S10U), manufactured by Hygea Medical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

FDA 510(k) Submission Details - K233140

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.

NEY Device Classification - Class 2, Special Controls

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 39
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