Self-Cath and Self-Cath Plus
K-Number: K221401 · 2022-12-02
Device Summary
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. The listed applicant is Coloplast. The 510(k) number is K221401.
When did Self-Cath and Self-Cath Plus receive FDA 510(k) clearance?
Self-Cath and Self-Cath Plus received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221401.
Who is the listed applicant for Self-Cath and Self-Cath Plus?
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 and Self-Cath Plus?
The FDA product code for Self-Cath and Self-Cath Plus is EZD.
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: EZD)
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.