Cleared Traditional

K031858 - NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES (FDA 510(k) Clearance)

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

K031858 · Richard Wolf Medical Instruments Corp. · Neurology device
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Jul 2004
Decision
409d
Days
Class 2
Risk

K031858 is an FDA 510(k) clearance for the NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELE.... 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 July 29, 2004 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K031858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date July 29, 2004
Days to Decision 409 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 148d · This submission: 409d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

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All 90
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