510(k) K254094
K254094 is an FDA 510(k) premarket notification submitted by Whiteley USA, Inc. for the device "Endox High Level Disinfectant". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2026
- Date Received
- Dec 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type
- 510(k)