Cleared Traditional

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K992461 · Surgical Navigation Technologies, Inc. · Neurology
Feb 2000
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K992461 is an FDA 510(k) clearance for the STEALTHSTATION TREATMENT GUIDANCE PLATFORM, 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 February 22, 2000, 214 days after receiving the submission on July 23, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K992461 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1999
Decision Date February 22, 2000
Days to Decision 214 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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