510(k) K232241

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

K232241 is an FDA 510(k) premarket notification submitted by Betters(Suzhou) Medical Co., Ltd. for the device "Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)". The FDA issued a decision of Substantially Equivalent on November 13, 2023. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Betters(Suzhou) Medical Co., Ltd. has at least 1 other 510(k) clearance on record.