Cleared Traditional

K971511 - RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE

K971511 is an FDA 510(k) clearance for RADIONICS CONTOUR FLEX 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 87-day FDA review.

K971511 · Radionics, Inc. · Neurology device
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Jul 1997
Decision
87d
Days
Class 2
Risk

K971511 is an FDA 510(k) clearance for the RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS 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 July 24, 1997 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K971511

510(k) Number K971511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date July 24, 1997
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 K971511.
MAURICE WORLDWIDE SHUNT SYSTEM
K973525 · Integra Neurocare, LLC · Dec 1997
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
K972994 · Integra Neurocare, LLC · Nov 1997
ENDOSCOPIC VENTRICULAR CATHETER
K971617 · Integra Neurocare, LLC · Jul 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc. · Jun 1997
PERITONEAL/CARDIAC CATHETER
K970983 · Integra Neurocare, LLC · Jun 1997
RADIONICS BURR HOLE VALVE
K970578 · Radionics, Inc. · Jun 1997