Cleared Abbreviated

CRW STEREOTACTIC SYSTEM

K160811 · Integra LifeSciences Corporation · Neurology
Dec 2016
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K160811 is an FDA 510(k) clearance for the CRW STEREOTACTIC SYSTEM, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 6, 2016, 257 days after receiving the submission on March 24, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K160811 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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