Ecential Robotics 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
Op.n Spine Navigation and Robotic Guidance510(k)Jul 22, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2026
Op.n(TM) Navigation510(k)Mar 7, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 7, 2025
Spine Navigation and Robotic-Assistance Device510(k)Jun 14, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2024
SURGIVISIO Device510(k)Jul 27, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jul 27, 2023
SURGIVISIO Device510(k)Jul 6, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
SURGIVISIO Device510(k)Apr 15, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 15, 2022
SURGIVISIO Device510(k)Mar 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 18, 2022