DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER— 510(k) K941488

Name: FDA 510(k) clearance K941488
Creator: U.S. Food and Drug Administration
Published: 1994-11-30

Substantially Equivalent

Medical Technology Development Corp.

FDA 510(k) clearance K941488 for DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER, Substantially Equivalent on 1994-11-30. Applicant: Medical Technology Development Corp.. Device class: 2.

Clearance details

Applicant: Medical Technology Development Corp.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-28
Decision date: 1994-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ynez, CA, US

Download summary PDF View on FDA.gov ↗

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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.