Cleared Traditional

OLYMPUS ENDOARM (K043128) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043128 · Olympus Corporation · Neurology device
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Dec 2004
Decision
39d
Days
Class 2
Risk

K043128 is an FDA 510(k) clearance for the OLYMPUS ENDOARM. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Olympus Corporation (Melville, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 39 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 Olympus Corporation devices

Submission Details

510(k) Number K043128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2004
Decision Date December 21, 2004
Days to Decision 39 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 148d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 40
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K043128.
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · KARL STORZ Endoscopy-America, Inc. · Sep 2016
MINOP Disposable Introducer 26F
K142315 · Aesculap, Inc. · Nov 2014
KSEA CLEARVISION II, MODEL 40334120
K072410 · KARL STORZ Endoscopy-America, Inc. · May 2008
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · KARL STORZ Endoscopy-America, Inc. · Jun 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · Aesculap, Inc. · Mar 2002
KSEA MINIATURE NEUROENDOSCOPE
K002704 · KARL STORZ Endoscopy-America, Inc. · Nov 2000