Ga Health Company Limited FDA Approvals

0 new drug approvals and 7 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
ANDORATE® Valve Kit510(k)Oct 16, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 16, 2023
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing510(k)Aug 1, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Aug 1, 2023
ANDORATE® Valve Kit510(k)Jul 7, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 7, 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve510(k)May 11, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 11, 2023
AquaPulse® Irrigation Tubing510(k)Nov 10, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Nov 10, 2022
andorate Suction Valve, andorate Air/Water Valve510(k)Jan 12, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 12, 2022
Andorate Universal Endoscope Tip Guard510(k)Mar 5, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 5, 2021