K212301 is an FDA 510(k) clearance for the Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on November 15, 2021, 115 days after receiving the submission on July 23, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K212301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2021 |
| Decision Date | November 15, 2021 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |