K231117 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, LLC, A Bioventus Company (Farmingdale, US). The FDA issued a Cleared decision on June 23, 2023, 64 days after receiving the submission on April 20, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K231117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2023 |
| Decision Date | June 23, 2023 |
| Days to Decision | 64 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |