AMERICAN DILATATION SYSTEM— 510(k) K853274

Substantially Equivalent

American Endoscopy, Inc.

FDA 510(k) clearance K853274 for AMERICAN DILATATION SYSTEM, Substantially Equivalent on 1985-10-17. Applicant: American Endoscopy, Inc..

Clearance details

Applicant: American Endoscopy, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1985-08-05
Decision date: 1985-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.