510(k) K233504
K233504 is an FDA 510(k) premarket notification submitted by W&H Sterilization S.R.L. for the device "Lexa MINI (RIS-303, RIS-305)". The FDA issued a decision of Substantially Equivalent on February 8, 2024. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. W&H Sterilization S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2024
- Date Received
- October 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type