Apex Locator— 510(k) K231990

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K231990 for Apex Locator, Substantially Equivalent on 2024-02-13. Applicant: Cefla S.C..

Clearance details

Applicant: Cefla S.C.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2023-07-05
Decision date: 2024-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola, IT

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.