L.T.C. 1000 URINARY DRAINAGE BAG— 510(k) K895957

Substantially Equivalent

Intl. Medical Marketing, Inc.

FDA 510(k) clearance K895957 for L.T.C. 1000 URINARY DRAINAGE BAG, Substantially Equivalent on 1989-10-24. Applicant: Intl. Medical Marketing, Inc..

Clearance details

Applicant: Intl. Medical Marketing, Inc.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-11
Decision date: 1989-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridge, NY, 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.