Cleared Traditional

neXus Ultrasonic Surgical Aspirator System (K190160) - FDA 510(k) Clearance

K190160 · Misonix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
120d
Days
-
Risk

K190160 is an FDA 510(k) clearance for the neXus Ultrasonic Surgical Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 30, 2019 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Misonix, Inc. devices

Submission Details

510(k) Number K190160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2019
Decision Date May 30, 2019
Days to Decision 120 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 53
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K190160.
Kogent Torus Ultrasonic Aspirator
K192963 · Katalyst Surgical, LLC · Jun 2020
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
K191555 · Ethicon Endo-Surgery, LLC · Feb 2020
Ultrasonic Surgical System
K190281 · Medisonic Technology CO · Oct 2019
Sonopet iQ Ultrasonic Aspirator System
K190070 · Stryker Corporation · Apr 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
K190180 · Integra LifeSciences Corporation · Apr 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
K182809 · Integra LifeSciences Corporation · Dec 2018