Actuated Medical, Inc. FDA Approvals

0 new drug approvals and 4 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
GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100510(k)Oct 31, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 31, 2025
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models510(k)Oct 4, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 4, 2024
GripTract-GI Endoscopic Tissue Manipulator510(k)Nov 3, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 3, 2023
IO Needle Safety Sheath510(k)Oct 31, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 31, 2022