THIN FILM DRESSING FOR ULTRASOUND EXAM— 510(k) K011284

Name: FDA 510(k) clearance K011284
Creator: U.S. Food and Drug Administration
Published: 2001-06-20

Substantially Equivalent

Martin E. Wendelken

FDA 510(k) clearance K011284 for THIN FILM DRESSING FOR ULTRASOUND EXAM, Substantially Equivalent on 2001-06-20. Applicant: Martin E. Wendelken. Device class: 2.

Clearance details

Applicant: Martin E. Wendelken
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2001-04-27
Decision date: 2001-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmwood Park, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.