Zhejiang Soudon Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 5 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 Stone Retrieval Balloon Catheter510(k)May 8, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 8, 2026
Disposable Stone Extraction Basket510(k)Apr 3, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 3, 2026
Disposable Hemostatic Clips510(k)Jan 26, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 26, 2024
Disposable Endoscope Injection Needles510(k)Nov 9, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 9, 2023
Disposable Sphincterotome510(k)Nov 7, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2023