K190281 is an FDA 510(k) clearance for the Ultrasonic Surgical System. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Medisonic Technology CO (Las Vegas, US). The FDA issued a Cleared decision on October 31, 2019, 262 days after receiving the submission on February 11, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K190281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | October 31, 2019 |
| Days to Decision | 262 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |