Cleared Traditional

K942413 - CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE E...

K942413 is an FDA 510(k) clearance for CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE E..., manufactured by Clarus Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K942413 · Clarus Medical Systems, Inc. · Neurology device
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Nov 1994
Decision
186d
Days
Class 2
Risk

K942413 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR. 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 November 22, 1994 after a review of 186 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

FDA 510(k) Submission Details - K942413

510(k) Number K942413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date November 22, 1994
Days to Decision 186 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
38d slower than avg
Panel avg: 148d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K942413.
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
PS MEDICAL CATHETER PLACEMENT KIT
K940096 · Pudenz-Schulte Medical Research Corp. · May 1994
CODMAN QUICK SHUNT KIT, CAT. #82-6570
K934196 · Codman & Shurtleff, Inc. · Apr 1994