Cleared Traditional

EASYDRILL AUTOSTOP CRANIAL PERFORATOR

K141455 · Micromar Ind. Com. , Ltd. · Neurology

Mar 2015

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K141455 is an FDA 510(k) clearance for the EASYDRILL AUTOSTOP CRANIAL PERFORATOR, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by Micromar Ind. Com. , Ltd. (Fort Worth, US). The FDA issued a Cleared decision on March 16, 2015, 287 days after receiving the submission on June 2, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number	K141455 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2014
Decision Date	March 16, 2015
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF