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FDA 510(k)

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

K-Number: K221593 · 2022-11-17

ApplicantConvatec, Inc.
Decision Date2022-11-17
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is a medical device manufactured by Convatec, Inc.. It received FDA 510(k) clearance on 2022-11-17 under approval number K221593. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is a medical device that received FDA 510(k) clearance on 2022-11-17. It is manufactured by Convatec, Inc.. The 510(k) number is K221593.

When was Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus approved by the FDA?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus received FDA 510(k) clearance on 2022-11-17, under approval number K221593.

What company makes Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is manufactured by Convatec, Inc..

What is the FDA product code for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

The FDA product code for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is EZD.

Other Devices by Convatec, Inc.

K230400Cure Catheter Closed System; Cure Dextra Closed System

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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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