Cleared Traditional

K992457 - SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION

K992457 is an FDA 510(k) clearance for SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SU..., manufactured by Surgical Navigation Specialists, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K992457 · Surgical Navigation Specialists, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
35d
Days
Class 2
Risk

K992457 is an FDA 510(k) clearance for the SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Surgical Navigation Specialists, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on August 27, 1999 after a review of 35 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 Surgical Navigation Specialists, Inc. devices

FDA 510(k) Submission Details - K992457

510(k) Number K992457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date August 27, 1999
Days to Decision 35 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
113d faster than avg
Panel avg: 148d · This submission: 35d
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 321
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K992457.
@ TARGET
K983410 · Brainlab AG · Sep 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992721 · Radionics, Inc. · Sep 1999
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K992304 · Image-Guided Neurologics, Inc. · Aug 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · Image-Guided Neurologics, Inc. · Aug 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · Elekta Instrument AB · Jul 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