Cleared Traditional

K972398 - STEALTHSTATION PASSIVE INSTRUMENT OPTION
(FDA 510(k) Clearance)

K972398 · Surgical Navigation Technologies, Inc. · Neurology

Sep 1997

Decision

82d

Days

Class 2

Risk

K972398 is an FDA 510(k) clearance for the STEALTHSTATION PASSIVE INSTRUMENT OPTION, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on September 16, 1997, 82 days after receiving the submission on June 26, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K972398 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 1997
Decision Date	September 16, 1997
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF