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FDA 510(k)

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

K-Number: K232241 · 2023-11-13

ApplicantBetters(Suzhou) Medical Co., Ltd.
Decision Date2023-11-13
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is a medical device manufactured by Betters(Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-11-13 under approval number K232241. 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 Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)?

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is a medical device that received FDA 510(k) clearance on 2023-11-13. It is manufactured by Betters(Suzhou) Medical Co., Ltd.. The 510(k) number is K232241.

When was Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) approved by the FDA?

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) received FDA 510(k) clearance on 2023-11-13, under approval number K232241.

What company makes Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)?

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is manufactured by Betters(Suzhou) Medical Co., Ltd..

What is the FDA product code for Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)?

The FDA product code for Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is NEY.

Related Clinical Trials

NCT05053555 High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies RECRUITING NCT03775980 CIRSE Emprint Microwave Ablation Registry COMPLETED NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT07226869 Computer Guided Microwave Liver Ablation RECRUITING NCT00102544 Use of Tracking Devices to Locate Abnormalities During Invasive Procedures ENROLLING_BY_INVITATION NCT06869122 Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK RECRUITING

Other Devices by Betters(Suzhou) Medical Co., Ltd.

K232240Microwave Ablation System (BD-GT)

Related Devices (Code: NEY)

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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.

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