Cleared Traditional

K970162 - NEUROLOGICAL ENDOSCOPE

K970162 is an FDA 510(k) clearance for NEUROLOGICAL ENDOSCOPE, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K970162 · Richard Wolf Medical Instruments Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
286d
Days
Class 2
Risk

K970162 is an FDA 510(k) clearance for the NEUROLOGICAL ENDOSCOPE. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on October 29, 1997 after a review of 286 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K970162

510(k) Number K970162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date October 29, 1997
Days to Decision 286 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 148d · This submission: 286d
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 84
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K970162.
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K982837 · Karl Storz Endoscopy · Nov 1998
OLYMPUS NEURO ENDOSCOPE
K971340 · Olympus Optical, Co. · Jul 1998
INCL II ENDOSCOPE
K963642 · Sofamor Danek USA,Inc. · Mar 1998
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · Aesculap, Inc. · Apr 1997
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
K965078 · Neuro Navigational Corp. · Mar 1997
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
K960915 · Clarus Medical Systems, Inc. · Dec 1996