510(k) K220040 ยท HCG Device, Neurovascular Embolization
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
| Applicant | Medos International SARL, Le Locle, CH |
| Decision | Substantially Equivalent, Jul 14, 2022 |
| Received | Jan 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | Cerenovus Inc CEREPAK Detachable Coil System - Name/REF:
UNIFORM 2MM X 2.5 CM/FCX100202,
UNIFORM 2.5MM X 3.3 CM/FCX100253,
UNIFORM 3MM X 5.4 CM/FCX100305,
UNIFORM 3.5MM X 6.6 CM/FCX100356,
UNIFORM 4MM X 7.5 CM/FCX1 Open, Classified |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.