Cleared Traditional

K040943 - MEDTRONIC PS MEDICAL STRATA VALVE

K040943 is an FDA 510(k) clearance for MEDTRONIC PS MEDICAL STRATA VALVE, 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 64-day FDA review.

K040943 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
64d
Days
Class 2
Risk

K040943 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL STRATA VALVE. 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 June 15, 2004 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Neurosurgery devices

FDA 510(k) Submission Details - K040943

510(k) Number K040943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2004
Decision Date June 15, 2004
Days to Decision 64 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
84d faster than avg
Panel avg: 148d · This submission: 64d
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 K040943.
EQUI-FLOW VALVE AND SHUNT SYSTEM
K042558 · Integra Neurosciences Implants S.A. · Oct 2004
PS MEDICAL NEUROSURGICAL IMPLANTS
K042198 · Medtronic Neurosurgery · Sep 2004
LOW FLOW OSV II HYDROCEPHALUS VALVE
K042192 · Integra Neurosciences Implants S.A. · Sep 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850 · Medtronic Neurosurgery · Jan 2004
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc. · Jun 2003