Cleared Traditional

K080355 - LEKSELL STEREOTACTIC SYSTEM WITH REUSAB...

K080355 is the FDA 510(k) clearance for LEKSELL STEREOTACTIC SYSTEM WITH REUSAB... by Elekta Instrument AB. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K080355 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
445d
Days
Class 2
Risk

K080355 is an FDA 510(k) clearance for the LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS. 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 May 1, 2009 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Elekta Instrument AB devices

Submission Details

510(k) Number K080355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date May 01, 2009
Days to Decision 445 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
297d slower than avg
Panel avg: 148d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 217
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