Cleared Special

K152558 - Leksell Stereotactic System, Injection/ Aspiration Needle Kit

K152558 is an FDA 510(k) clearance for Leksell Stereotactic System, manufactured by Elekta Instrument AB. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 175-day FDA review.

K152558 · Elekta Instrument AB · Neurology device
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Mar 2016
Decision
175d
Days
Class 2
Risk

K152558 is an FDA 510(k) clearance for the Leksell Stereotactic System, Injection/ Aspiration Needle Kit. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on March 2, 2016 after a review of 175 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. 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 - K152558

510(k) Number K152558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date March 02, 2016
Days to Decision 175 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 149d · This submission: 175d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K152558.
Fiagon Navigation System
K151156 · Fiagon GmbH · Apr 2016
BrightMatter Guide with Surface Trace Registration
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ClearPoint System
K160434 · Mri Interventions, Inc. · Mar 2016
ROSA Brain
K151359 · Medtech S.A · Dec 2015
SYMBIS Surgical System
K143420 · Imris, Inc. · Oct 2015
ClearPoint System
K142505 · Mri Interventions, Inc. · Oct 2015
K152558 · Leksell Stereotactic System, Injection/ Aspiration Needle Kit
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