K190160 is an FDA 510(k) clearance for the neXus Ultrasonic Surgical Aspirator System. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 30, 2019, 120 days after receiving the submission on January 30, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K190160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2019 |
| Decision Date | May 30, 2019 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |