URINARY DRAINAGE UNIT— 510(k) K890551

Substantially Equivalent

Consolidated Products & Services, Inc.

FDA 510(k) clearance K890551 for URINARY DRAINAGE UNIT, Substantially Equivalent on 1989-02-28. Applicant: Consolidated Products & Services, Inc..

Clearance details

Applicant
Consolidated Products & Services, Inc.
Product code
Code KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Quincy, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

Source: openFDA MAUDE database, through . 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.