Phenox Limited FDA Approvals

0 new drug approvals and 3 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
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device510(k)Feb 28, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Feb 28, 2025
pRESET LITE Thrombectomy Device510(k)Oct 21, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 21, 2023
pRESET Thrombectomy Device510(k)Jan 20, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 20, 2023