510(k) K211273

Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray by Ethicon Endo-Surgery, LLC — Product Code LFL

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