ULTRA EXTERNAL CATHETER— 510(k) K844801

Substantially Equivalent

Inmed Corp.

FDA 510(k) clearance K844801 for ULTRA EXTERNAL CATHETER, Substantially Equivalent on 1985-01-15. Applicant: Inmed Corp..

Clearance details

Applicant: Inmed Corp.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1984-12-11
Decision date: 1985-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, 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.