Cleared Traditional

K965078 - 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0...

K965078 is an FDA 510(k) clearance for 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0..., 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 77-day FDA review.

K965078 · Neuro Navigational Corp. · Neurology device
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Mar 1997
Decision
77d
Days
Class 2
Risk

K965078 is an FDA 510(k) clearance for the 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS. 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 6, 1997 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuro Navigational Corp. devices

FDA 510(k) Submission Details - K965078

510(k) Number K965078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date March 06, 1997
Days to Decision 77 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
71d faster than avg
Panel avg: 148d · This submission: 77d
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 K965078.
INCL II ENDOSCOPE
K963642 · Sofamor Danek USA,Inc. · Mar 1998
NEUROLOGICAL ENDOSCOPE
K970162 · Richard Wolf Medical Instruments Corp. · Oct 1997
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · Aesculap, Inc. · Apr 1997
NEUROVIEW SCISSORS
K961406 · Neuro Navigational Corp. · Jun 1996
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
K961173 · Neuro Navigational Corp. · Jun 1996
ASPIRATION/IRRIGATION CATHETER
K961300 · Neuro Navigational Corp. · Jun 1996