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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-07-17 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K173654.

When did Ureteral Dilator Sets, Ureteral Dilators receive FDA 510(k) clearance?

Ureteral Dilator Sets, Ureteral Dilators received FDA 510(k) clearance on 2018-07-17, under 510(k) number K173654.

Who is the listed applicant for Ureteral Dilator Sets, Ureteral Dilators?

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 Ureteral Dilator Sets, Ureteral Dilators?

The FDA product code for Ureteral Dilator Sets, Ureteral Dilators is EZN.

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Related Devices (Code: EZN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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