ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)— 510(k) K013276

Name: FDA 510(k) clearance K013276
Creator: U.S. Food and Drug Administration
Published: 2002-02-15

Substantially Equivalent

Sewoon Medical Co., Ltd.

FDA 510(k) clearance K013276 for ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE), Substantially Equivalent on 2002-02-15. Applicant: Sewoon Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sewoon Medical Co., Ltd.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2001-10-01
Decision date: 2002-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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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.