510(k) K211273
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2021
- Date Received
- April 27, 2021
- 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