K130616

Substantially Equivalent

MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES

Applicant: Biopsybell S.R.L.
Product code: KNW
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-07
Decision date: 2014-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Verona, NJ, 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.