510(k) K211273
K211273 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray". The FDA issued a decision of Substantially Equivalent on May 21, 2021. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Ethicon Endo-Surgery, LLC has at least 10 other 510(k) clearances on record.
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