ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865— 510(k) K021142

Substantially Equivalent

Fortune Medical Instrument Corp.

FDA 510(k) clearance K021142 for ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865, Substantially Equivalent on 2002-10-01. Applicant: Fortune Medical Instrument Corp..

Clearance details

Applicant: Fortune Medical Instrument Corp.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-09
Decision date: 2002-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.