510(k) K212178— Root Apex Locator

Substantially Equivalent

Foshan Coxo Medical Instrument Co., Ltd.

Clearance details

Applicant: Foshan Coxo Medical Instrument Co., Ltd.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2021-07-12
Decision date: 2022-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.