Cleared Traditional

neXus Ultrasonic Surgical Aspirator System (K221235) - FDA 510(k) Clearance

K221235 · Misonix, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
90d
Days
-
Risk

K221235 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 July 28, 2022 after a review of 90 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 K221235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2022
Decision Date July 28, 2022
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

Misonix
John Salerno

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 53
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