Cleared Abbreviated

K160811 - CRW STEREOTACTIC SYSTEM

K160811 is the FDA 510(k) clearance for CRW STEREOTACTIC SYSTEM by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code HAW) cleared through the Abbreviated 510(k) pathway after a 257-day FDA review.

K160811 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
257d
Days
Class 2
Risk

K160811 is an FDA 510(k) clearance for the CRW STEREOTACTIC SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 6, 2016 after a review of 257 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Integra LifeSciences Corporation devices

Submission Details

510(k) Number K160811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2016
Decision Date December 06, 2016
Days to Decision 257 days
Submission Type Abbreviated
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
109d slower than avg
Panel avg: 148d · This submission: 257d
Pathway characteristics
Standards-based clearance path.

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 K160811.
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K162929 · Stryker Corporation · Feb 2017
Cranial Reducing Tubes
K162604 · Medtronic Navigation, Inc. · Dec 2016
StealthStation System with Cranial Software
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Leksell Stereotactic System, Injection/ Aspiration Needle Kit
K152558 · Elekta Instrument AB · Mar 2016
Synergy Cranial
K150216 · Medtronic Navigation, Inc. · Jun 2015