Cleared Traditional

K040979 - ELEKTA MICRODRIVE, MODEL 916716

K040979 is an FDA 510(k) clearance for ELEKTA MICRODRIVE, manufactured by Elekta Instrument AB. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K040979 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF)
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Jul 2004
Decision
99d
Days
Class 2
Risk

K040979 is an FDA 510(k) clearance for the ELEKTA MICRODRIVE, MODEL 916716. 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 July 23, 2004 after a review of 99 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. 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 Instrument AB devices

FDA 510(k) Submission Details - K040979

510(k) Number K040979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2004
Decision Date July 23, 2004
Days to Decision 99 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
49d faster than avg
Panel avg: 148d · This submission: 99d
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 K040979.
IPLAN! FLOW
K041330 · Brainlab AG · Sep 2004
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K033341 · Smith & Nephew, Inc. · Sep 2004
VECTORVISION HIP 3.0
K040368 · Brainlab AG · Aug 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc. · Jul 2004
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
K041369 · Orthosoft, Inc. · Jun 2004
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
K040834 · Image-Guided Neurologics, Inc. · Jun 2004