SILICATH ALL SILICONE FOLEY CATHETER— 510(k) K945806

Name: FDA 510(k) clearance K945806
Creator: U.S. Food and Drug Administration
Published: 1995-03-21

Substantially Equivalent

Unomedical Sdn Bhd

FDA 510(k) clearance K945806 for SILICATH ALL SILICONE FOLEY CATHETER, Substantially Equivalent on 1995-03-21. 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: 1994-11-28
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungai Petani, Kedah, MY

Download summary PDF View on FDA.gov ↗

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K241424 — InnoCare Specialty Foley Catheter2024-09-18

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K973076 — EUROMEDICAL HAEMATURIA FOLEY CATHETER1998-09-16
K962389 — EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE1996-11-21
K954750 — PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE1995-12-08
K954751 — SILICONE ENDOTRACHEAL TUBE1995-12-08
K954753 — PEDIATRIC 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.