Cleared Traditional

K973684 - LEKSELL VIEWSCOPE

K973684 is the FDA 510(k) clearance for LEKSELL VIEWSCOPE by Elekta Instrument AB. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K973684 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
186d
Days
Class 2
Risk

K973684 is an FDA 510(k) clearance for the LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (San Diego, US). The FDA issued a Cleared decision on March 31, 1998 after a review of 186 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 Instrument AB devices

Submission Details

510(k) Number K973684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date March 31, 1998
Days to Decision 186 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
38d slower than avg
Panel avg: 148d · This submission: 186d
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
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K973684.
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc. · Aug 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · Radionics, Inc. · Jul 1998
ATLASPLAN
K980584 · Radionics, Inc. · May 1998
LEKSELL STEREOTACTIC SYSTEM
K972324 · Elekta Instrument AB · Mar 1998
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc. · May 1997
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K965139 · Carl Zeiss, Inc. · Apr 1997