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FDA 510(k)

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent

K-Number: K172278 · 2017-11-22

ApplicantCook Incorporated
Decision Date2017-11-22
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-11-22 under approval number K172278. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent?

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Cook Incorporated. The 510(k) number is K172278.

When was Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent approved by the FDA?

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent received FDA 510(k) clearance on 2017-11-22, under approval number K172278.

What company makes Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent?

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is manufactured by Cook Incorporated.

What is the FDA product code for Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent?

The FDA product code for Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is GBM.

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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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