Cleared Traditional

K913490 - PHOENIX BURR HOLE BUTTON, BURR 1

K913490 is an FDA 510(k) clearance for PHOENIX BURR HOLE BUTTON, manufactured by Phoenix Bioengineering, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K913490 · Phoenix Bioengineering, Inc. · Neurology device
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Jan 1992
Decision
160d
Days
Class 2
Risk

K913490 is an FDA 510(k) clearance for the PHOENIX BURR HOLE BUTTON, BURR 1. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Phoenix Bioengineering, Inc. (Bridgeport, US). The FDA issued a Cleared decision on January 13, 1992 after a review of 160 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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 Phoenix Bioengineering, Inc. devices

FDA 510(k) Submission Details - K913490

510(k) Number K913490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date January 13, 1992
Days to Decision 160 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 148d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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.