BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR— 510(k) K851470

Substantially Equivalent

Lic-Orthion

FDA 510(k) clearance K851470 for BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR, Substantially Equivalent on 1985-06-12. Applicant: Lic-Orthion.

Clearance details

Applicant: Lic-Orthion
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1985-04-15
Decision date: 1985-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.