MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System— 510(k) K192099

Substantially Equivalent

Medax Srl Unipersonale

FDA 510(k) clearance K192099 for MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System, Substantially Equivalent on 2020-04-02. Applicant: Medax Srl Unipersonale.

Clearance details

Applicant: Medax Srl Unipersonale
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2019-08-05
Decision date: 2020-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poggio Rusco, IT

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.