neXus Ultrasonic Surgical Aspirator System
FDA 510(k) K261448 · Misonix, LLC
510(k) numberK261448
Submission
- Device name
- neXus Ultrasonic Surgical Aspirator System
- Applicant
- Misonix, LLC
Farmingdale, NY, US - Received
- May 1, 2026
- Decision date
- July 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
Other 510(k)s with product code LFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/08/2025SE |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic…LFL · Traditional | Shanghai Saints Sages Surgical Co., Ltd. | 06/18/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | Stryker Instruments | 03/24/2025SE |
| K241700 | Tenex 2nd Generation SystemLFL · Traditional | Trice Medical, Inc. | 11/18/2024SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2024SE |
| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2023SE |
| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
| K223770 | Sonopet 1Q 3 7cm 1Q LargeLFL · Traditional | Stryker Corporation | 02/16/2023SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K221235 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/28/2022SE |
| K212060 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 12/13/2021SE |
| K190160 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 05/30/2019SE |
| K123980 | Sonicone Plus Ultrasound Wound Care System and AccessoriesNRB · Special | 03/05/2013SE |
| K112782 | Misonix Sonicone(R) Ultrasonic Wound Care System and AccessoriesNRB · Traditional | 12/01/2011SE |
| K070779 | Sonatherm 600I Ultrasonic Lesion Generating SystemNTB · Traditional | 07/09/2008SE |
| K070313 | Misonix, Inc., AUSS-7 Ultrasonic Surgical Aspirator SystemLFL · Special | 05/11/2007SE |
| K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RFLFL · Traditional | 10/26/2006SE |
| K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemNTB · Traditional | 01/26/2006SE |
| K052702 | Misonix Inc. FS-1000-RF Bipolar Forceps AccessoryGEI · Traditional | 11/21/2005SE |
Questions and answers
When was neXus Ultrasonic Surgical Aspirator System cleared by the FDA?
neXus Ultrasonic Surgical Aspirator System (K261448) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 90 days after the submission was received.
What is the product code of K261448?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.