Cleared Traditional

STEALTHSTATION SYSTEM

K974161 · Surgical Navigation Technologies, Inc. · Neurology
Nov 1997
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K974161 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM, 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 November 21, 1997, 86 days after receiving the submission on August 27, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K974161 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1997
Decision Date November 21, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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