SpeedCath Compact Male
K-Number: K210250 · 2022-04-26
ApplicantColoplast
Decision Date2022-04-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SpeedCath Compact Male is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2022-04-26 under approval number K210250. 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 SpeedCath Compact Male?
SpeedCath Compact Male is a medical device that received FDA 510(k) clearance on 2022-04-26. It is manufactured by Coloplast. The 510(k) number is K210250.
When was SpeedCath Compact Male approved by the FDA?
SpeedCath Compact Male received FDA 510(k) clearance on 2022-04-26, under approval number K210250.
What company makes SpeedCath Compact Male?
SpeedCath Compact Male is manufactured by Coloplast.
What is the FDA product code for SpeedCath Compact Male?
The FDA product code for SpeedCath Compact Male 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.