Cleared Special

Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

K211273 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery
May 2021
Decision
24d
Days
—
Risk

About This 510(k) Submission

K211273 is an FDA 510(k) clearance for the Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray, a Instrument, Ultrasonic Surgical, submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on May 21, 2021, 24 days after receiving the submission on April 27, 2021. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K211273 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2021
Decision Date May 21, 2021
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class —

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