Cleared Traditional

K992916 - BRAINLAB STEREOTACTIC ARC

K992916 is an FDA 510(k) clearance for BRAINLAB STEREOTACTIC ARC, manufactured by Brainlab. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K992916 · Brainlab · Neurology device
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Jan 2000
Decision
134d
Days
Class 2
Risk

K992916 is an FDA 510(k) clearance for the BRAINLAB STEREOTACTIC ARC. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab (Redwood City, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 134 days - within the typical 510(k) review window.

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 Brainlab devices

FDA 510(k) Submission Details - K992916

510(k) Number K992916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1999
Decision Date January 11, 2000
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 148d · This submission: 134d
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 K992916.
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · Surgical Navigation Technologies, Inc. · Feb 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · Stryker Corp. · Jan 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992927 · Surgical Navigation Technologies, Inc. · Dec 1999
SNN FLUORO NAVIGATION SYSTEM
K993673 · I.S.G. Technologies, Inc. · Dec 1999
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · Stryker Corp. · Dec 1999