Cleared Special

K033340 - LEKSELL SURGIPLAN WITH IMAGEMERGE

K033340 is an FDA 510(k) clearance for LEKSELL SURGIPLAN WITH IMAGEMERGE, 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 118-day FDA review.

K033340 · Elekta Instrument AB · Neurology device
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Feb 2004
Decision
118d
Days
Class 2
Risk

K033340 is an FDA 510(k) clearance for the LEKSELL SURGIPLAN WITH IMAGEMERGE. 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 February 12, 2004 after a review of 118 days - within the typical 510(k) review window.

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 - K033340

510(k) Number K033340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2003
Decision Date February 12, 2004
Days to Decision 118 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
31d faster than avg
Panel avg: 149d · This submission: 118d
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 K033340.
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · Zimmer, Inc. · Feb 2004
VECTORVISION CRANIAL/ENT
K023651 · Brainlab AG · Feb 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc. · Feb 2004
NDI PASSIVE SPHERES
K033621 · Northern Digital, Inc. · Jan 2004
SPINEASSIST DEVICE
K033413 · Mazor Surgical Technologies , Ltd. · Jan 2004
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
K032917 · Orthosoft, Inc. · Oct 2003
K033340 · LEKSELL SURGIPLAN WITH IMAGEMERGE
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