Cleared Abbreviated

MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (K003914) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K003914 · Medtronic PS Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
65d
Days
Class 2
Risk

K003914 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on February 22, 2001 after a review of 65 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medtronic PS Medical devices

Submission Details

510(k) Number K003914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date February 22, 2001
Days to Decision 65 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
Pathway characteristics
Standards-based clearance path.

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 92
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K003914.
Precision S 4K Sinuscope
K253602 · Stryker Endoscopy · Jun 2026
Hydro Irrigation System
K253679 · Stryker Instruments · May 2026
HJY VisualNext 3D Endoscopic Vision System
K243429 · Hjy Smart Medical Device Co., Ltd. · May 2025
AURORA® Surgiscope® System (ASX15/60)
K250752 · Integra LifeSciences Corporation · Apr 2025
cCeLL - In vivo
K233391 · VPIX Medical, Inc. · Aug 2024
Digital ClarusScope System, Digital NeuroPEN System
K223615 · Clarus Medical, LLC · Nov 2023