510(k) K250434
K250434 is an FDA 510(k) premarket notification submitted by Nanosonics for the device "trophon2". The FDA issued a decision of Substantially Equivalent on Aug 5, 2025. The device falls under product code OUJ (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist), a Class II device regulated under 21 CFR 892.1570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2025
- Date Received
- Feb 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- HO
- Submission Type
To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).