Cleared Traditional

IPC POWEREASE SYSTEM

K111520 · Medtronic Xomed, Inc. · Neurology
Oct 2011
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K111520 is an FDA 510(k) clearance for the IPC POWEREASE SYSTEM, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 26, 2011, 146 days after receiving the submission on June 2, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K111520 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2011
Decision Date October 26, 2011
Days to Decision 146 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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