Clearance Summary
Lexa MINI (RIS-303, RIS-305) received FDA 510(k) clearance under submission number K223858, sponsored by W&H Sterilization S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-05-05.
- Submission: K223858
- Applicant / Sponsor: W&H Sterilization S.R.L.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2023-05-05
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.