Cleared Special

CUSA Excel+ Ultrasonic Surgical Aspirator System

K172595 · Integra LifeSciences Corporation · General & Plastic Surgery
Sep 2017
Decision
30d
Days
Risk

About This 510(k) Submission

K172595 is an FDA 510(k) clearance for the CUSA Excel+ Ultrasonic Surgical Aspirator System, a Instrument, Ultrasonic Surgical, submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on September 28, 2017, 30 days after receiving the submission on August 29, 2017. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K172595 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2017
Decision Date September 28, 2017
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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