Cleared Traditional

K970578 - RADIONICS BURR HOLE VALVE

K970578 is an FDA 510(k) clearance for RADIONICS BURR HOLE VALVE, manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K970578 · Radionics, Inc. · Neurology device
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Jun 1997
Decision
110d
Days
Class 2
Risk

K970578 is an FDA 510(k) clearance for the RADIONICS BURR HOLE VALVE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 110 days - within the typical 510(k) review window.

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 Radionics, Inc. devices

FDA 510(k) Submission Details - K970578

510(k) Number K970578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1997
Decision Date June 04, 1997
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
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 223
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K970578.
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511 · Radionics, Inc. · Jul 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc. · Jun 1997
PERITONEAL/CARDIAC CATHETER
K970983 · Integra Neurocare, LLC · Jun 1997
LUMBAR DRAINAGE ACCESSORY KIT
K970658 · Integra Neurocare, LLC · May 1997
SHUNT TAP WITH ICP MONITORING ACCESS PORT
K964371 · Integra Neurocare, LLC · Jan 1997
RADIONICS CONTOUR FLEX PLUS VALVE
K964386 · Radionics, Inc. · Jan 1997