Cleared Traditional

K232241 - Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (FDA 510(k) Clearance)

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

K232241 · Betters(Suzhou) Medical Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2023
Decision
108d
Days
Class 2
Risk

K232241 is an FDA 510(k) clearance for the Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815,.... 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

Submission Details

510(k) Number K232241 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
6d faster than avg
Panel avg: 114d · This submission: 108d
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 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 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K232241.
Microwave Ablation Device
K252632 · Nanjing Dewen Medical Technology Co., Ltd. · Mar 2026
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
K253771 · Nanjing Devin Medical Technology Co., Ltd. · Mar 2026
swiftPro System (SWF-SPS)
K250718 · Emblation Limited · Aug 2025
Microwave Ablation Generator (KY-2000A, KY-2100A)
K241827 · Canyon Medical, Inc. · Sep 2024
Microwave Ablation Antennas
K241825 · Canyon Medical, Inc. · Sep 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · Varian Medical Systems, Inc. · Jul 2024