CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE— 510(k) K832290

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K832290 for CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE, Substantially Equivalent on 1984-07-31. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1983-07-13
Decision date: 1984-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.