Cleared Special

K070313 - MISONIX

K070313 · Misonix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
99d
Days
-
Risk

K070313 is an FDA 510(k) clearance for the MISONIX, INC., AUSS-7 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 11, 2007 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Misonix, Inc. devices

FDA 510(k) Submission Details - K070313

510(k) Number K070313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2007
Decision Date May 11, 2007
Days to Decision 99 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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