Cleared Traditional

K032303 - STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (FDA 510(k) Clearance)

K032303 · Stryker Instruments · Neurology device

Jan 2004

Decision

175d

Days

Class 2

Risk

K032303 is an FDA 510(k) clearance for the STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 16, 2004, 175 days after receiving the submission on July 25, 2003.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K032303 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 25, 2003
Decision Date	January 16, 2004
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF