K220040 is an FDA 510(k) clearance for the CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on July 14, 2022, 190 days after receiving the submission on January 5, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K220040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2022 |
| Decision Date | July 14, 2022 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG — Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |