Cleared Traditional

K091312 - PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

K091312 is an FDA 510(k) clearance for PS MEDICAL STRATA NSC LUMBOPERITONEAL V..., manufactured by Medtronic Neurosurgery. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K091312 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
121d
Days
Class 2
Risk

K091312 is an FDA 510(k) clearance for the PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on September 2, 2009 after a review of 121 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Neurosurgery devices

FDA 510(k) Submission Details - K091312

510(k) Number K091312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date September 02, 2009
Days to Decision 121 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
27d faster than avg
Panel avg: 148d · This submission: 121d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K091312.
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003 · Aesculap, Inc. · Nov 2010
OSV II LOW FLOW LOW PRO VALVE
K093968 · Integra LifeSciences Corporation · Jan 2010
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395 · Integra Lifesciences Corp. · Nov 2009
CODMAN HAKIM MICRO II VALVE
K091346 · Codman & Shurtleff, Inc. · Jun 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
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