PRE-FILLED SYRINGE & CYSTOFLO URINARY BG— 510(k) K811924

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K811924 for PRE-FILLED SYRINGE & CYSTOFLO URINARY BG, Substantially Equivalent on 1981-11-10. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1981-07-02
Decision date: 1981-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.