# W&H Sterilization S.R.L.

- Location (FDA's records): Brusaporto, IT
- FDA decisions: 4 (2018–2024): 4 510(k) clearances
- Product codes: FLE (4)
- 510(k) review time since 2016: median 254 days, against 133 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K233504: Lexa MINI (RIS-303, RIS-305) (Feb 8, 2024)
- K223858: Lexa MINI (RIS-303, RIS-305) (May 5, 2023)
- K213758: Lexa PLUS RIS-311 (Aug 19, 2022)
- K172825: MN-111 (May 30, 2018)

Source page: https://510kreport.com/company/w-h-sterilization