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FDA 510(k)

Safety Wire Guide Introducer

K-Number: K180756 · 2018-05-24

ApplicantCook Incorporated
Decision Date2018-05-24
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Safety Wire Guide Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K180756. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Wire Guide Introducer?

Safety Wire Guide Introducer is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Cook Incorporated. The 510(k) number is K180756.

When did Safety Wire Guide Introducer receive FDA 510(k) clearance?

Safety Wire Guide Introducer received FDA 510(k) clearance on 2018-05-24, under 510(k) number K180756.

Who is the listed applicant for Safety Wire Guide Introducer?

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

What is the FDA product code for Safety Wire Guide Introducer?

The FDA product code for Safety Wire Guide Introducer is EZN.

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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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