Cleared Traditional

AESCULAP PNEUMATIC KERRISON

K062413 · Aesculap, Inc. · Neurology

Nov 2006

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K062413 is an FDA 510(k) clearance for the AESCULAP PNEUMATIC KERRISON, a Rongeur, Powered (Class II — Special Controls, product code HAD), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 21, 2006, 96 days after receiving the submission on August 17, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4845.

Submission Details

510(k) Number	K062413 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2006
Decision Date	November 21, 2006
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF