510(k) K220040— CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

Substantially Equivalent

Medos International SARL

Clearance details

Applicant: Medos International SARL
Product code: Code HCG
Advisory panel: Neurology
Date received: 2022-01-05
Decision date: 2022-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.