Cleared Traditional

K022942 - CRANIOCUT (FDA 510(k) Clearance)

K022942 · Aesculap, Inc. · Neurology device

Oct 2002

Decision

46d

Days

Class 2

Risk

K022942 is an FDA 510(k) clearance for the CRANIOCUT. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 21, 2002, 46 days after receiving the submission on September 5, 2002.

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

Submission Details

510(k) Number	K022942 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 05, 2002
Decision Date	October 21, 2002
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF