510(k) K260254
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2026
- Date Received
- January 27, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type