Vathin® Video Bronchoscope System— 510(k) K223836

Substantially Equivalent

Hunan Vathin Medical Instrument Co., Ltd.

FDA 510(k) clearance K223836 for Vathin® Video Bronchoscope System, Substantially Equivalent on 2023-05-15. Applicant: Hunan Vathin Medical Instrument Co., Ltd..

Clearance details

Applicant: Hunan Vathin Medical Instrument Co., Ltd.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2022-12-22
Decision date: 2023-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiangtan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.