Cleared Traditional

K943468 - LEKSELL SURGIPLAN

K943468 is an FDA 510(k) clearance for LEKSELL SURGIPLAN, manufactured by Elekta Instruments, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K943468 · Elekta Instruments, Inc. · Neurology device
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Jan 1995
Decision
185d
Days
Class 2
Risk

K943468 is an FDA 510(k) clearance for the LEKSELL SURGIPLAN. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instruments, Inc. (Atlanta, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 185 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 Elekta Instruments, Inc. devices

FDA 510(k) Submission Details - K943468

510(k) Number K943468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date January 20, 1995
Days to Decision 185 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 148d · This submission: 185d
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 298
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K943468.
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · Codman & Shurtleff, Inc. · Feb 1996
BRAINLAB STEROTATIC HEADRING
K952390 · Brainlab Med. Computersysteme GmbH · Feb 1996
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp. · Mar 1994
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · Nomos Corp. · Aug 1993
AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
K924348 · Ad-Tech Medical Instrument Corp · Nov 1992