Cleared Traditional

K111520 - IPC POWEREASE SYSTEM (FDA 510(k) Clearance)

K111520 · Medtronic Xomed, Inc. · Neurology device

Oct 2011

Decision

146d

Days

Class 2

Risk

K111520 is an FDA 510(k) clearance for the IPC POWEREASE SYSTEM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K111520 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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