Cleared Traditional

K191687 - pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (FDA 510(k) Clearance)

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

K191687 · Phenox Limited · Neurology device
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Oct 2019
Decision
107d
Days
Class 2
Risk

K191687 is an FDA 510(k) clearance for the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Phenox Limited (Galway, IE). The FDA issued a Cleared decision on October 9, 2019 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - 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 Phenox Limited devices

Submission Details

510(k) Number K191687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2019
Decision Date October 09, 2019
Days to Decision 107 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
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 762
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