CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT— 510(k) K880034

Substantially Equivalent

Lin-Mark, Inc.

FDA 510(k) clearance K880034 for CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT, Substantially Equivalent on 1988-03-02. Applicant: Lin-Mark, Inc..

Clearance details

Applicant: Lin-Mark, Inc.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-05
Decision date: 1988-03-02
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.