Cleared Traditional

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

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

K212060 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 December 13, 2021 after a review of 165 days - an extended review cycle.

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 K212060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 53
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