Self-Cath Closed System
K-Number: K223821 · 2023-08-02
Device Summary
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. The listed applicant is Coloplast. The 510(k) number is K223821.
When did Self-Cath Closed System receive FDA 510(k) clearance?
Self-Cath Closed System received FDA 510(k) clearance on 2023-08-02, under 510(k) number K223821.
Who is the listed applicant for Self-Cath Closed System?
The FDA 510(k) record lists Coloplast as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-Cath Closed System?
The FDA product code for Self-Cath Closed System is FCM.
Other records listing Coloplast as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FCM)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.