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FDA 510(k)

SureCath Set

K-Number: K242049 · 2024-11-26

ApplicantColoplast Corp.
Decision Date2024-11-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SureCath Set is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2024-11-26 under approval number K242049. 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 SureCath Set?

SureCath Set is a medical device that received FDA 510(k) clearance on 2024-11-26. It is manufactured by Coloplast Corp.. The 510(k) number is K242049.

When was SureCath Set approved by the FDA?

SureCath Set received FDA 510(k) clearance on 2024-11-26, under approval number K242049.

What company makes SureCath Set?

SureCath Set is manufactured by Coloplast Corp..

What is the FDA product code for SureCath Set?

The FDA product code for SureCath Set is EZD.

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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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