Cleared Traditional

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

K082010 · Stryker Ireland Ltd., Instruments Division · Neurology

Dec 2008

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K082010 is an FDA 510(k) clearance for the STRYKER DISPOSABLE CRANIAL PERFORATOR BIT, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by Stryker Ireland Ltd., Instruments Division (Carrigtwohill, Co.Cork, IE). The FDA issued a Cleared decision on December 29, 2008, 167 days after receiving the submission on July 15, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number	K082010 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2008
Decision Date	December 29, 2008
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF