neXus Ultrasonic Surgical Aspirator System— 510(k) K261448
Substantially EquivalentMisonix, LLC
FDA 510(k) clearance K261448 for neXus Ultrasonic Surgical Aspirator System, Substantially Equivalent on 2026-07-30. Applicant: Misonix, LLC. Device class: Unclassified.
Summary
Misonix's neXus Ultrasonic Surgical Aspirator System is filed under LFL, ultrasonic surgical instruments. The record doesn't list the system's components.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Misonix filed from Farmingdale, New York. Review took 90 calendar days (May 1 to July 30, 2026).
Clearance details
- Applicant
- Misonix, LLC
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingdale, NY, US
Recent devices under product code LFL
view all- K261361 — TORUS Ultrasonic Aspirator System +1 more
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- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more
- K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.