The following data is part of a premarket notification filed by Misonix Inc. with the FDA for Nexus Ultrasonic Surgical Aspirator System.
| Device ID | K221235 |
| 510k Number | K221235 |
| Device Name: | NeXus Ultrasonic Surgical Aspirator System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Misonix Inc. 1938 New Highway Farmingdale, NY 11735 |
| Contact | John Salerno |
| Correspondent | John Salerno Misonix 1938 New Highway Farmingdale, NY 11735 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-07-28 |