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

Name: FDA 510(k) clearance K223858
Creator: U.S. Food and Drug Administration
Published: 2023-05-05

Substantially Equivalent

W&H Sterilization S.R.L.

FDA 510(k) clearance K223858 for Lexa MINI (RIS-303, RIS-305), Substantially Equivalent on 2023-05-05. Applicant: W&H Sterilization S.R.L.. Device class: 2.

Clearance details

Applicant: W&H Sterilization S.R.L.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2022-12-23
Decision date: 2023-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brusaporto, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLE

view all

K261055 — AMSCO 700 Steam Sterilizer2026-06-24
K260254 — Enbio PRO2026-02-26
K252307 — Getinge GSS67N Series Steam Sterilizer2026-01-22
K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2025-12-30
K250164 — Cassette Autoclave (ACA5)2025-08-14

More clearances from W&H Sterilization S.R.L.

view all

K233504 — Lexa MINI (RIS-303, RIS-305)2024-02-08
K213758 — Lexa PLUS RIS-3112022-08-19
K172825 — MN-1112018-05-30

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.