Cleared Traditional

K142344 - DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

K142344 is an FDA 510(k) clearance for DISPOSABLE PASSIVE ACCESSORY FOR MEDTRO..., manufactured by Izi Medical Products, LLC. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K142344 · Izi Medical Products, LLC · Neurology device
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Mar 2015
Decision
210d
Days
Class 2
Risk

K142344 is an FDA 510(k) clearance for the DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Izi Medical Products, LLC (Owings Mills, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 210 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Izi Medical Products, LLC devices

FDA 510(k) Submission Details - K142344

510(k) Number K142344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2014
Decision Date March 20, 2015
Days to Decision 210 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
62d slower than avg
Panel avg: 148d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 331
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K142344.
MDT Navigable Brain Biopsy Cannula
K143241 · Izi Medical Products, LLC · Apr 2015
BRIGHTMATTER NAVIGATION SYSTEM
K142024 · Synaptive Medical, Inc. · Apr 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K141833 · Medtronic Navigation, Inc. · Mar 2015
V-GUIDE FOR VENTRICULOSTOMIES
K141559 · Arc Surgical, LLC · Feb 2015
NAVIGABLE BRAIN BIOPSY CANNULA SET
K140705 · Izi Medical Products · Dec 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · Medtronic Navigation, Inc. · Jul 2014