Cleared Traditional

K062471 - ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (FDA 510(k) Clearance)

Oct 2006
Decision
63d
Days
-
Risk

K062471 is an FDA 510(k) clearance for the ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on October 26, 2006, 63 days after receiving the submission on August 24, 2006.

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

Submission Details

510(k) Number K062471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date October 26, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL - Instrument, Ultrasonic Surgical
Device Class -

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