HS NOTA— 510(k) K131925

Substantially Equivalent

H.S. Hospital Services S.P.A.

FDA 510(k) clearance K131925 for HS NOTA, Substantially Equivalent on 2014-10-10. Applicant: H.S. Hospital Services S.P.A..

Clearance details

Applicant: H.S. Hospital Services S.P.A.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-26
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.