K180149 is an FDA 510(k) clearance for the Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on March 26, 2018, 66 days after receiving the submission on January 19, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K180149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2018 |
| Decision Date | March 26, 2018 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |