Human Xtensions , 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
HandX Self-Righting Needle Holder510(k)Jun 5, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 5, 2023
HandX Monopolar Scissors510(k)May 10, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 10, 2023
HandX Instrument - Monopolar Spatula510(k)Jan 12, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jan 12, 2023
HandX510(k)Sep 13, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2021
Monopolar Hook510(k)Feb 1, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 1, 2021