Endobronchial Tube— 510(k) K152251

Substantially Equivalent

Henan Tuoren Medical Device Co., Ltd.

FDA 510(k) clearance K152251 for Endobronchial Tube, Substantially Equivalent on 2016-06-10. Applicant: Henan Tuoren Medical Device Co., Ltd..

Clearance details

Applicant: Henan Tuoren Medical Device Co., Ltd.
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2015-08-10
Decision date: 2016-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinxiang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.