K221790 is an FDA 510(k) clearance for the HARMONIC 700 Shears. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on February 28, 2023, 252 days after receiving the submission on June 21, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K221790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2022 |
| Decision Date | February 28, 2023 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |