Precision Robotics (Hong Kong) Limited FDA Approvals

0 new drug approvals and 2 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
SIRIUS Endoscope System (PR-SI-1230)510(k)Aug 29, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Aug 29, 2025
SIRIUS Endoscope System510(k)Dec 12, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Dec 12, 2022