Cleared Traditional

K033660 - STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
(FDA 510(k) Clearance)

K033660 · Rudolf Storz GmbH · Neurology device

Jan 2004

Decision

47d

Days

Class 2

Risk

K033660 is an FDA 510(k) clearance for the STORZ RANEY SCALP CLIP, MODEL 1-20-004-05. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).

Submitted by Rudolf Storz GmbH (Amsterdam, NL). The FDA issued a Cleared decision on January 7, 2004, 47 days after receiving the submission on November 21, 2003.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.

Submission Details

510(k) Number	K033660 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 21, 2003
Decision Date	January 07, 2004
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement