510(k) K223858— Lexa MINI (RIS-303, RIS-305)

Substantially Equivalent

W&H Sterilization S.R.L.

Clearance details

Applicant: W&H Sterilization S.R.L.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2022-12-23
Decision date: 2023-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brusaporto, IT

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.