K233504
- 510(k) number
- K233504
- Device name
- Lexa MINI (RIS-303, RIS-305)
- Applicant
- W&H Sterilization S.R.L. IT
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2024-02-08
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233504
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.