Alton (Shanghai) Medical Instruments Co., Ltd. FDA Approvals

0 new drug approvals and 6 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
Ureteral Stents (AF-D series)510(k)Jun 18, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 18, 2025
Endoscopic Distal Attachment (AF-D series)510(k)May 30, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 30, 2025
Disposable Cytology Brush (AF series)510(k)Mar 4, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Mar 4, 2025
Disposable Endoscope Valves Set (AF series)510(k)Oct 1, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 1, 2024
Disposable Hemoclip (AF series)510(k)Jan 11, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 11, 2024
Disposable Injection Needle AF series510(k)Sep 27, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 27, 2023