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FDA 510(k)

Urethrotech UCD

K-Number: K190060 · 2019-10-04

ApplicantUrethrotech
Decision Date2019-10-04
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Urethrotech UCD is a medical device manufactured by Urethrotech. It received FDA 510(k) clearance on 2019-10-04 under approval number K190060. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Urethrotech UCD?

Urethrotech UCD is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Urethrotech. The 510(k) number is K190060.

When was Urethrotech UCD approved by the FDA?

Urethrotech UCD received FDA 510(k) clearance on 2019-10-04, under approval number K190060.

What company makes Urethrotech UCD?

Urethrotech UCD is manufactured by Urethrotech.

What is the FDA product code for Urethrotech UCD?

The FDA product code for Urethrotech UCD is EZL.

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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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