OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver— 510(k) K230015

Substantially Equivalent

Laurane Medical Sas

FDA 510(k) clearance K230015 for OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver, Substantially Equivalent on 2023-06-16. Applicant: Laurane Medical Sas.

Clearance details

Applicant: Laurane Medical Sas
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2023-01-03
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Pradet, FR

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.