UNILYTE A— 510(k) K843623

Substantially Equivalent

Medical Enterprises, Ltd.

FDA 510(k) clearance K843623 for UNILYTE A, Substantially Equivalent on 1984-11-16. Applicant: Medical Enterprises, Ltd..

Clearance details

Applicant: Medical Enterprises, Ltd.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1984-08-21
Decision date: 1984-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.