COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM— 510(k) K844684

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K844684 for COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM, Substantially Equivalent on 1985-01-08. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1984-11-30
Decision date: 1985-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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