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)
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.

View all Integra Neurosciences Implants S.A. devices

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
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 148d · 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 203
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K081773.
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STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127 · Medtronic Neurosurgery · Aug 2008
SMALL LUMEN PERITONEAL CATHETER
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LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
K072929 · Integra LifeSciences Corporation · Dec 2007