Cleared Traditional

K961639 - LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)

K961639 is an FDA 510(k) clearance for LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM ..., 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 88-day FDA review.

K961639 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
88d
Days
Class 2
Risk

K961639 is an FDA 510(k) clearance for the LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS). 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 26, 1996 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elekta Instrument AB devices

FDA 510(k) Submission Details - K961639

510(k) Number K961639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date July 26, 1996
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 332
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K961639.
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
K961844 · Radionics Software Applications, Inc. · Oct 1996
BRAINLAB HEADPINS
K954789 · Brainlab AG · Aug 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961858 · Radionics, Inc. · Aug 1996
ISG VIEWING WAND
K960714 · I.S.G. Technologies, Inc. · May 1996
MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
K961120 · Howmedica Leibinger, Inc. · May 1996
MAYFIELD-ACCISS WORKSTATION
K955397 · Nomos Corp. · Apr 1996