Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22— 510(k) K193542

Substantially Equivalent

Bellco Srl

FDA 510(k) clearance K193542 for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22, Substantially Equivalent on 2020-10-08. Applicant: Bellco Srl.

Clearance details

Applicant: Bellco Srl
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2019-12-20
Decision date: 2020-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.