MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES— 510(k) K130616

Substantially Equivalent

Biopsybell S.R.L.

FDA 510(k) clearance K130616 for MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES, Substantially Equivalent on 2014-02-07. Applicant: Biopsybell S.R.L..

Clearance details

Applicant: Biopsybell S.R.L.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.