K200427 is an FDA 510(k) clearance for the Sonicision Cordless Ultrasonic Dissector. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on July 10, 2020, 140 days after receiving the submission on February 21, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K200427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2020 |
| Decision Date | July 10, 2020 |
| Days to Decision | 140 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |