Cleared Traditional

K991636 - ELEKTA STEREOTACTIC GUIDE

K991636 is an FDA 510(k) clearance for ELEKTA STEREOTACTIC GUIDE, 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 69-day FDA review.

K991636 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
69d
Days
Class 2
Risk

K991636 is an FDA 510(k) clearance for the ELEKTA STEREOTACTIC GUIDE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (Lake Forest, US). The FDA issued a Cleared decision on July 20, 1999 after a review of 69 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 - K991636

510(k) Number K991636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1999
Decision Date July 20, 1999
Days to Decision 69 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
79d faster than avg
Panel avg: 148d · This submission: 69d
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 333
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K991636.
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K992304 · Image-Guided Neurologics, Inc. · Aug 1999
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
K992457 · Surgical Navigation Specialists, Inc. · Aug 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · Image-Guided Neurologics, Inc. · Aug 1999
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
K991267 · Ohio Medical Instrument Co., Inc. · Jul 1999
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc. · Jul 1999
FRAMELESS NEUROMATE
K991081 · Integrated Surgical Systems, Inc. · Jun 1999