Cleared Traditional

MERIDIAN CRANIAL PERFORATOR

K121253 · Adeor Medical Technologies GmbH · Neurology

Jul 2012

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K121253 is an FDA 510(k) clearance for the MERIDIAN CRANIAL PERFORATOR, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by Adeor Medical Technologies GmbH (Pullach, DE). The FDA issued a Cleared decision on July 17, 2012, 83 days after receiving the submission on April 25, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number	K121253 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2012
Decision Date	July 17, 2012
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF