Betters(Suzhou) Medical Co., Ltd. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)510(k)Nov 13, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 13, 2023
Microwave Ablation System (BD-GT)510(k)Nov 13, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 13, 2023