Lexa MINI (RIS-303, RIS-305)— 510(k) K233504

Substantially Equivalent

W&H Sterilization S.R.L.

FDA 510(k) clearance K233504 for Lexa MINI (RIS-303, RIS-305), Substantially Equivalent on 2024-02-08. Applicant: 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: 2023-10-31
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brusaporto, IT

Download summary PDF View on FDA.gov ↗

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.