Cleared Special

K060681 - MEDTRONIC PS MEDICAL STRATA TYPE VALUE

K060681 is an FDA 510(k) clearance for MEDTRONIC PS MEDICAL STRATA TYPE VALUE, manufactured by Medtronic Neurosurgery. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 184-day FDA review.

K060681 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
184d
Days
Class 2
Risk

K060681 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL STRATA TYPE VALUE. 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 15, 2006 after a review of 184 days - an extended review cycle.

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 - K060681

510(k) Number K060681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date September 15, 2006
Days to Decision 184 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
35d slower than avg
Panel avg: 149d · This submission: 184d
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 258
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K060681.
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K052386 · Medtronic Neurosurgery · Dec 2005
K060681 · MEDTRONIC PS MEDICAL STRATA TYPE VALUE
Download PDF FDA Summary Medtronic Neurosurgery