Cleared Special

K081773 - OSV II

K081773 is an FDA 510(k) clearance for OSV II, manufactured by Integra Neurosciences Implants S.A.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 136-day FDA review.

K081773 · Integra Neurosciences Implants S.A. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
136d
Days
Class 2
Risk

K081773 is an FDA 510(k) clearance for the OSV II. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Neurosciences Implants S.A. (Planisboro, US). The FDA issued a Cleared decision on November 6, 2008 after a review of 136 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081773

510(k) Number K081773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2008
Decision Date November 06, 2008
Days to Decision 136 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
13d faster than avg
Panel avg: 149d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K081773.
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K090348 · Codman & Shurtleff, Inc. · Mar 2009
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
K083076 · Medtronic Neurosurgery · Nov 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127 · Medtronic Neurosurgery · Aug 2008
NEUROCATH AG
K081942 · Vygon Neuro · Aug 2008
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
K080168 · Neuro Diagnostic Devices · May 2008
K081773 · OSV II
Download PDF FDA Summary Integra Neurosciences…