510(k) K190180
K190180 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 April 1, 2019. 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
- April 1, 2019
- Date Received
- February 1, 2019
- 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