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FDA 510(k)

CRW STEREOTACTIC SYSTEM

K-Number: K160811 · 2016-12-06

ApplicantIntegra LifeSciences Corporation
Decision Date2016-12-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRW STEREOTACTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K160811. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRW STEREOTACTIC SYSTEM?

CRW STEREOTACTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K160811.

When did CRW STEREOTACTIC SYSTEM receive FDA 510(k) clearance?

CRW STEREOTACTIC SYSTEM received FDA 510(k) clearance on 2016-12-06, under 510(k) number K160811.

Who is the listed applicant for CRW STEREOTACTIC SYSTEM?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRW STEREOTACTIC SYSTEM?

The FDA product code for CRW STEREOTACTIC SYSTEM is HAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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