ORION RED URETHRAL CATHETER— 510(k) K944383

Substantially Equivalent

Regulatory & Marketing Services, Inc.

FDA 510(k) clearance K944383 for ORION RED URETHRAL CATHETER, Substantially Equivalent on 1994-12-06. Applicant: Regulatory & Marketing Services, Inc..

Clearance details

Applicant: Regulatory & Marketing Services, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-07
Decision date: 1994-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.