Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)— 510(k) K172344

Substantially Equivalent

Medax Srl Unipersonale

FDA 510(k) clearance K172344 for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK), Substantially Equivalent on 2017-11-13. Applicant: Medax Srl Unipersonale.

Clearance details

Applicant: Medax Srl Unipersonale
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2017-08-02
Decision date: 2017-11-13
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.