NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337— 510(k) K083667

Name: FDA 510(k) clearance K083667
Creator: U.S. Food and Drug Administration
Published: 2009-02-02

Substantially Equivalent

B-K Medical Aps

FDA 510(k) clearance K083667 for NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337, Substantially Equivalent on 2009-02-02. Applicant: B-K Medical Aps. Device class: 2.

Clearance details

Applicant: B-K Medical Aps
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2008-12-11
Decision date: 2009-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herlev, DK

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.