FDA 510(k)

Microwave Ablation System (BD-GT)

K-Number: K232240 · 2023-11-13

ApplicantBetters(Suzhou) Medical Co., Ltd.

Decision Date2023-11-13

Product CodeNEY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Microwave Ablation System (BD-GT) is a medical device manufactured by Betters(Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-11-13 under approval number K232240. 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 System (BD-GT)?

Microwave Ablation System (BD-GT) 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 K232240.

When was Microwave Ablation System (BD-GT) approved by the FDA?

Microwave Ablation System (BD-GT) received FDA 510(k) clearance on 2023-11-13, under approval number K232240.

What company makes Microwave Ablation System (BD-GT)?

Microwave Ablation System (BD-GT) is manufactured by Betters(Suzhou) Medical Co., Ltd..

What is the FDA product code for Microwave Ablation System (BD-GT)?

The FDA product code for Microwave Ablation System (BD-GT) is NEY.

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

K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.