Cleared Traditional

SNT DISPOSABLE BIOPSY NEEDLE

K971247 · Surgical Navigation Technologies, Inc. · Neurology
Jun 1997
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K971247 is an FDA 510(k) clearance for the SNT DISPOSABLE BIOPSY NEEDLE, 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 June 16, 1997, 74 days after receiving the submission on April 3, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K971247 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1997
Decision Date June 16, 1997
Days to Decision 74 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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