Cleared Special

K161992 - Horizontal-Vertical Lumbar Valve Systems

K161992 is the FDA 510(k) clearance for Horizontal-Vertical Lumbar Valve Systems by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code JXG) cleared through the Special 510(k) pathway after a 65-day FDA review.

K161992 · Integra LifeSciences Corporation · Neurology device
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Sep 2016
Decision
65d
Days
Class 2
Risk

K161992 is an FDA 510(k) clearance for the Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Sy.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 65 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra LifeSciences Corporation devices

Submission Details

510(k) Number K161992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2016
Decision Date September 22, 2016
Days to Decision 65 days
Submission Type Special
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
83d faster than avg
Panel avg: 148d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K161992.
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · Codman & Shurtleff, Inc. · Oct 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
K161853 · Aesculap, Inc. · Feb 2017
Codman EDS3 CSF External Drainage System
K162437 · Codman & Shurtleff, Inc. · Oct 2016
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
K153041 · Integra LifeSciences Corporation · Mar 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K152897 · Integra LifeSciences Corporation · Mar 2016
Codman Certas Plus Programmable Valve
K152152 · Medos International SARL · Oct 2015