K153371 is an FDA 510(k) clearance for the Sonicision 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 March 28, 2016, 126 days after receiving the submission on November 23, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K153371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2015 |
| Decision Date | March 28, 2016 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |