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 by Medos International SARL — Product Code HCG

K220040 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems". The FDA issued a decision of Substantially Equivalent on July 14, 2022. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Medos International SARL has at least 10 other 510(k) clearances on record.