NAVIGABLE BRAIN BIOPSY CANNULA SET— 510(k) K140705

Substantially Equivalent

Izi Medical Products

FDA 510(k) clearance K140705 for NAVIGABLE BRAIN BIOPSY CANNULA SET, Substantially Equivalent on 2014-12-05. Applicant: Izi Medical Products.

Clearance details

Applicant: Izi Medical Products
Product code: Code HAW
Advisory panel: Neurology
Date received: 2014-03-21
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Owings Mills, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.