Point Robotics MedTech, Inc. 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
POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set510(k)Feb 20, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 20, 2026
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System510(k)Jan 23, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 23, 2026
POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)510(k)Jul 24, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 24, 2024
POINT Kinguide Agile Hybrid Navigation System510(k)Jul 17, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 17, 2023
POINT Kinguide Robotic-Assisted Surgical System510(k)Aug 9, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 9, 2022