Cleared Traditional

K192703 - Cranial Image Guided Surgery System

K192703 is the FDA 510(k) clearance for Cranial Image Guided Surgery System by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K192703 · Brainlab AG · Neurology device
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Oct 2020
Decision
377d
Days
Class 2
Risk

K192703 is an FDA 510(k) clearance for the Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation .... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on October 8, 2020 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 AG devices

Submission Details

510(k) Number K192703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date October 08, 2020
Days to Decision 377 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
229d slower than avg
Panel avg: 148d · This submission: 377d
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 225
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K192703.
Disposable Pre-calibrated Suction
K201752 · Brainlab AG · Jan 2021
ClearPoint Array System
K202575 · ClearPoint Neuro, Inc. · Jan 2021
StealthStation Cranial Software v1.3.2
K203639 · Medtronic Navigation, Inc. · Jan 2021
StealthStation Cranial Software v1.3.0
K201175 · Medtronic Navigation, Inc. · Jun 2020
ROSA ONE Brain application
K200511 · Medtech S.A · May 2020
Neural Navigator
K191422 · Soterix Medical, Inc. · Apr 2020