AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC— 510(k) K924348

Substantially Equivalent

Ad-Tech Medical Instrument Corp

FDA 510(k) clearance K924348 for AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC, Substantially Equivalent on 1992-11-23. Applicant: Ad-Tech Medical Instrument Corp.

Clearance details

Applicant
Ad-Tech Medical Instrument Corp
Product code
Code HAW
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Racine, WI, US
Download summary PDFView 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, through . 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.