SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER— 510(k) K860362

Name: FDA 510(k) clearance K860362
Creator: U.S. Food and Drug Administration
Published: 1986-04-29

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K860362 for SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER, Substantially Equivalent on 1986-04-29. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1986-01-30
Decision date: 1986-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, 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.