AKRO-SIL PLUS— 510(k) K864736

Substantially Equivalent

Akron Catheter, Inc.

FDA 510(k) clearance K864736 for AKRO-SIL PLUS, Substantially Equivalent on 1986-12-24. Applicant: Akron Catheter, Inc..

Clearance details

Applicant: Akron Catheter, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-04
Decision date: 1986-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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.