510(k) K231117
K231117 is an FDA 510(k) premarket notification submitted by Misonix, LLC, A Bioventus Company for the device "neXus Ultrasonic Surgical Aspirator System". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2023
- Date Received
- April 20, 2023
- Clearance Type
- Special
- 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