EUROMEDICAL HAEMATURIA FOLEY CATHETER— 510(k) K973076

Name: FDA 510(k) clearance K973076
Creator: U.S. Food and Drug Administration
Published: 1998-09-16

Substantially Equivalent

Unomedical Sdn Bhd

FDA 510(k) clearance K973076 for EUROMEDICAL HAEMATURIA FOLEY CATHETER, Substantially Equivalent on 1998-09-16. Applicant: Unomedical Sdn Bhd. Device class: 2.

Clearance details

Applicant: Unomedical Sdn Bhd
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1997-08-18
Decision date: 1998-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elfers, FL, US

Download summary PDF View on FDA.gov ↗

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K954750 — PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE1995-12-08
K954751 — SILICONE ENDOTRACHEAL TUBE1995-12-08
K954753 — PEDIATRIC SILICONE ENDOTRACHEAL TUBE1995-12-08
K954754 — WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE1995-12-08

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.