Decision Date2026-03-02
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Microwave Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Dewen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252632. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Microwave Ablation Device?
Microwave Ablation Device is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Nanjing Dewen Medical Technology Co., Ltd.. The 510(k) number is K252632.
When did Microwave Ablation Device receive FDA 510(k) clearance?
Microwave Ablation Device received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252632.
Who is the listed applicant for Microwave Ablation Device?
The FDA 510(k) record lists Nanjing Dewen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Microwave Ablation Device?
The FDA product code for Microwave Ablation Device is NEY.
Related Devices (Code: NEY)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K253771Disposable 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)Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation LimitedK241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.K241825Microwave Ablation AntennasCanyon Medical, Inc.K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.