SPIRALE DRUG DELIVERY SYSTEM— 510(k) K111246

Name: FDA 510(k) clearance K111246
Creator: U.S. Food and Drug Administration
Published: 2012-08-10

Substantially Equivalent

Armstrong Medical , Ltd.

FDA 510(k) clearance K111246 for SPIRALE DRUG DELIVERY SYSTEM, Substantially Equivalent on 2012-08-10. Applicant: Armstrong Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Armstrong Medical , Ltd.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2011-05-04
Decision date: 2012-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coleraine, IE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.