Apex Locator (AL-Pex), Apex Locator (AL-Pex+)— 510(k) K232717

Substantially Equivalent

Changzhou Haili Medical Co., Ltd.

FDA 510(k) clearance K232717 for Apex Locator (AL-Pex), Apex Locator (AL-Pex+), Substantially Equivalent on 2023-12-22. Applicant: Changzhou Haili Medical Co., Ltd..

Clearance details

Applicant: Changzhou Haili Medical Co., Ltd.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2023-09-05
Decision date: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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.