510(k) K251162
K251162 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "CUSA® Clarity Ultrasonic Surgical Aspirator System". The FDA issued a decision of Substantially Equivalent on October 8, 2025. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2025
- Date Received
- April 15, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type