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.
Clearance details
- Applicant
- Misonix, LLC
- Product code
- 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- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
- K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
- K241700 — Tenex 2nd Generation System
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
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.