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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