Cleared Traditional

K212060 - neXus Ultrasonic Surgical Aspirator System
(FDA 510(k) Clearance)

K212060 · Misonix, Inc. · General & Plastic Surgery
Dec 2021
Decision
165d
Days
Risk

K212060 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, Inc. (Farmingdale, US). The FDA issued a Cleared decision on December 13, 2021, 165 days after receiving the submission on July 1, 2021.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K212060 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2021
Decision Date December 13, 2021
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

Similar Devices — LFL Instrument, Ultrasonic Surgical

All 156
CUSA? Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
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)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
CUSA? Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
Ultrasonic Surgical System
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Jun 2024