Cleared Traditional

CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 (K945296) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945296 · Clarus Medical Systems, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
256d
Days
Class 2
Risk

K945296 is an FDA 510(k) clearance for the CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 256 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarus Medical Systems, Inc. devices

Submission Details

510(k) Number K945296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date July 14, 1995
Days to Decision 256 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 148d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 46
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K945296.
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · Aesculap, Inc. · Apr 1997
AESCULAP VENTRICULOSCOPE SYSTEM
K954394 · Aesculap, Inc. · Mar 1996
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · United States Surgical, A Division of Tyco Healthc · Oct 1995
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
K945572 · Johnson & Johnson Professionals, Inc. · Feb 1995
AESCULAP NEUROENDOSCOPE
K941239 · Aesculap, Inc. · Jul 1994
CODMAN QUICK SHUNT KIT, CAT. #82-6570
K934196 · Codman & Shurtleff, Inc. · Apr 1994