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 a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-05-24 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K180756.
When was Safety Wire Guide Introducer approved by the FDA?
Safety Wire Guide Introducer received FDA 510(k) clearance on 2018-05-24, under approval number K180756.
What company makes Safety Wire Guide Introducer?
Safety Wire Guide Introducer is manufactured by Cook Incorporated.
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.