Wei Nasal Jet Tube— 510(k) K211543

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K211543 for Wei Nasal Jet Tube, Substantially Equivalent on 2022-07-21. Applicant: Well Lead Medical Co., Ltd..

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2021-05-19
Decision date: 2022-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.