Self-Cath and Self-Cath Plus
K-Number: K221401 · 2022-12-02
ApplicantColoplast
Decision Date2022-12-02
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Self-Cath and Self-Cath Plus is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2022-12-02 under approval number K221401. 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 Self-Cath and Self-Cath Plus?
Self-Cath and Self-Cath Plus is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Coloplast. The 510(k) number is K221401.
When was Self-Cath and Self-Cath Plus approved by the FDA?
Self-Cath and Self-Cath Plus received FDA 510(k) clearance on 2022-12-02, under approval number K221401.
What company makes Self-Cath and Self-Cath Plus?
Self-Cath and Self-Cath Plus is manufactured by Coloplast.
What is the FDA product code for Self-Cath and Self-Cath Plus?
The FDA product code for Self-Cath and Self-Cath Plus 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.