Cleared Special

K013861 - MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE

K013861 is an FDA 510(k) clearance for MODIFICATION TO LEKSELL SURGIPLAN WITH ..., 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 15-day FDA review.

K013861 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
15d
Days
Class 2
Risk

K013861 is an FDA 510(k) clearance for the MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (Lake Forest, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 15 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K013861

510(k) Number K013861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date December 06, 2001
Days to Decision 15 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
134d faster than avg
Panel avg: 149d · This submission: 15d
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 K013861.
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc. · Feb 2002
KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K012937 · Medtronic Surgical Navigation Technologies · Jan 2002
3D LINE STEROTACTIC HARDWARE ACCESSORIES
K011255 · 3D Line USA, Inc. · Dec 2001
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
K012380 · Stryker Leibinger · Dec 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · Nuvasive, Inc. · Oct 2001
NAVIGUS II MR
K012719 · Image-Guided Neurologics, Inc. · Oct 2001
K013861 · MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
Download PDF FDA Summary Elekta Instrument AB