Cleared Traditional

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K992927 · Surgical Navigation Technologies, Inc. · Neurology
Dec 1999
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K992927 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 December 29, 1999, 120 days after receiving the submission on August 31, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K992927 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1999
Decision Date December 29, 1999
Days to Decision 120 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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