510(k) K973364— 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG

Substantially Equivalent

Maersk Medical A/S

Clearance details

Applicant: Maersk Medical A/S
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1997-09-08
Decision date: 1998-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harlev, DK

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.