Self-Cath Closed System
K-Number: K223821 · 2023-08-02
ApplicantColoplast
Decision Date2023-08-02
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Self-Cath Closed System is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2023-08-02 under approval number K223821. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Self-Cath Closed System?
Self-Cath Closed System is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Coloplast. The 510(k) number is K223821.
When was Self-Cath Closed System approved by the FDA?
Self-Cath Closed System received FDA 510(k) clearance on 2023-08-02, under approval number K223821.
What company makes Self-Cath Closed System?
Self-Cath Closed System is manufactured by Coloplast.
What is the FDA product code for Self-Cath Closed System?
The FDA product code for Self-Cath Closed System is FCM.
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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.