FOLEY CATHETERS— 510(k) K863517

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K863517 for FOLEY CATHETERS, Substantially Equivalent on 1986-10-31. Applicant: Instrumentation Industries, Inc..

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-09
Decision date: 1986-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

Download summary PDF View on FDA.gov ↗

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.