Cleared Special

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems

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

About This 510(k) Submission

K161992 is an FDA 510(k) clearance for the Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on September 22, 2016, 65 days after receiving the submission on July 19, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K161992 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — JXG Shunt, Central Nervous System And Components

All 257
Intellidrop
K251598 · Brainspace, Inc. · Dec 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · Sophysa · Nov 2025
EVAC-MRI
K252514 · Phasor Health, LLC · Nov 2025
Codman Libert?s Shunt Catheter with Bactiseal and Endexo Technology
K243531 · Integra Lifesciences Production Corporation · Aug 2025
Codman Libert?s? 1.5 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821761); Codman Libert?s? 1.9 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821762)
K243552 · Integra Lifesciences Production Corporation · Aug 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
K242974 · Sophysa · Jun 2025