Cleared Traditional

K013488 - SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM ...

K013488 is an FDA 510(k) clearance for SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM ..., manufactured by Sophysa SA. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K013488 · Sophysa SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
159d
Days
Class 2
Risk

K013488 is an FDA 510(k) clearance for the SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Sophysa SA (Wellesley, US). The FDA issued a Cleared decision on March 27, 2002 after a review of 159 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Sophysa SA devices

FDA 510(k) Submission Details - K013488

510(k) Number K013488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date March 27, 2002
Days to Decision 159 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
11d slower than avg
Panel avg: 148d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 181
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