Cleared Traditional

K954938 - DISPOSABLE NEUROVIEW OPERATING SHEATH

K954938 is an FDA 510(k) clearance for DISPOSABLE NEUROVIEW OPERATING SHEATH, manufactured by Neuro Navigational Corp.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K954938 · Neuro Navigational Corp. · Neurology device
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Mar 1996
Decision
129d
Days
Class 2
Risk

K954938 is an FDA 510(k) clearance for the DISPOSABLE NEUROVIEW OPERATING SHEATH. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Neuro Navigational Corp. (Costa Mesa, US). The FDA issued a Cleared decision on March 7, 1996 after a review of 129 days - within the typical 510(k) review window.

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 Neuro Navigational Corp. devices

FDA 510(k) Submission Details - K954938

510(k) Number K954938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date March 07, 1996
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
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 67
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K954938.
ASPIRATION/IRRIGATION CATHETER
K961300 · Neuro Navigational Corp. · Jun 1996
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
K960792 · Neuro Navigational Corp. · Apr 1996
AESCULAP VENTRICULOSCOPE SYSTEM
K954394 · Aesculap, Inc. · Mar 1996
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K955351 · Neuro Navigational Corp. · Feb 1996
RIGID NEUROVIEW ENDOSCOPE
K954899 · Neuro Navigational Corp. · Dec 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · United States Surgical, A Division of Tyco Healthc · Oct 1995