K981166

Substantially Equivalent

ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214

Applicant: Inrad
Product code: KNW
Advisory panel: Gastroenterology, Urology
Date received: 1998-03-31
Decision date: 1998-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kentwood, MI, US

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.