Shenzhen Insighters Medical Technology Co., Ltd. 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
Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1.510(k)May 28, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 28, 2025
Disposable Double Lumen Endobronchial Tube510(k)May 13, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 13, 2024
Disposable Endobronchial Blocker Tube510(k)Dec 14, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 14, 2023