Self-Cath Closed System— 510(k) K223821

Substantially Equivalent

Coloplast

FDA 510(k) clearance K223821 for Self-Cath Closed System, Substantially Equivalent on 2023-08-02. Applicant: Coloplast.

Clearance details

Applicant: Coloplast
Product code: Code FCM
Advisory panel: Gastroenterology, Urology
Date received: 2022-12-21
Decision date: 2023-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.