Ureteral Dilator Sets, Ureteral Dilators
K-Number: K173654 · 2018-07-17
ApplicantCook Incorporated
Decision Date2018-07-17
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ureteral Dilator Sets, Ureteral Dilators is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-07-17 under approval number K173654. 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 Ureteral Dilator Sets, Ureteral Dilators?
Ureteral Dilator Sets, Ureteral Dilators is a medical device that received FDA 510(k) clearance on 2018-07-17. It is manufactured by Cook Incorporated. The 510(k) number is K173654.
When was Ureteral Dilator Sets, Ureteral Dilators approved by the FDA?
Ureteral Dilator Sets, Ureteral Dilators received FDA 510(k) clearance on 2018-07-17, under approval number K173654.
What company makes Ureteral Dilator Sets, Ureteral Dilators?
Ureteral Dilator Sets, Ureteral Dilators is manufactured by Cook Incorporated.
What is the FDA product code for Ureteral Dilator Sets, Ureteral Dilators?
The FDA product code for Ureteral Dilator Sets, Ureteral Dilators 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.