MODIFICATION TO TEMNO BIOPSY NEEDLES— 510(k) K024120

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K024120 for MODIFICATION TO TEMNO BIOPSY NEEDLES, Substantially Equivalent on 2003-01-15. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2002-12-16
Decision date: 2003-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgaw Park, IL, US

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Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.