Cleared Traditional

SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM

K965139 · Carl Zeiss, Inc. · Neurology

Apr 1997

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K965139 is an FDA 510(k) clearance for the SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on April 23, 1997, 121 days after receiving the submission on December 23, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K965139 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1996
Decision Date	April 23, 1997
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF