K211273 is an FDA 510(k) clearance for the Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray. This device is classified as 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 FDA review panel.
| 510(k) Number | K211273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |