Cleared Traditional

K232240 - Microwave Ablation System (BD-GT)

K232240 is an FDA 510(k) clearance for Microwave Ablation System (BD-GT), manufactured by Betters(Suzhou) Medical 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 108-day FDA review.

K232240 · Betters(Suzhou) Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
108d
Days
Class 2
Risk

K232240 is an FDA 510(k) clearance for the Microwave Ablation System (BD-GT). Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Betters(Suzhou) Medical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 13, 2023 after a review of 108 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 Betters(Suzhou) Medical Co., Ltd. devices

FDA 510(k) Submission Details - K232240

510(k) Number K232240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date November 13, 2023
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
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 Consultant

APlus Healthcare Technology (Shanghai) Co., Ltd.
Ada Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K232240.
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
NEUWAVE™ Microwave Ablation System and Accessories
K231738 · Neuwave Medical, Inc. · 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
swiftPro System
K222388 · Emblation , Ltd. · May 2023