Cleared Traditional

K141668 - CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (FDA 510(k) Clearance)

Nov 2014
Decision
136d
Days
Risk

K141668 is an FDA 510(k) clearance for the CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Integra LifeSciences Corporation (Plainsboro, US). The FDA issued a Cleared decision on November 6, 2014, 136 days after receiving the submission on June 23, 2014.

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

Submission Details

510(k) Number K141668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date November 06, 2014
Days to Decision 136 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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