HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES— 510(k) K010448

Substantially Equivalent

Horizons Intl. Corp.

FDA 510(k) clearance K010448 for HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES, Substantially Equivalent on 2001-05-16. Applicant: Horizons Intl. Corp..

Clearance details

Applicant: Horizons Intl. Corp.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-15
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ponce, PR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK

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.