Sophysa 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
Pressio 3 Multi-parameter Neuromonitoring System510(k)Apr 10, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 10, 2026
Sophy Mini Monopressure Valve (SM1)510(k)Nov 28, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 28, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters510(k)Jun 20, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 20, 2025
Polaris Valve Electronic Reading Instrument510(k)Feb 2, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 2, 2023