New Medax Biopsy Systems— 510(k) K142125

Substantially Equivalent

Medax Srl Unipersonale

FDA 510(k) clearance K142125 for New Medax Biopsy Systems, Substantially Equivalent on 2015-12-22. Applicant: Medax Srl Unipersonale.

Clearance details

Applicant: Medax Srl Unipersonale
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2014-08-04
Decision date: 2015-12-22
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.