K232955 is an FDA 510(k) clearance for the Numen Coil Embolization System. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by MicroPort NeuroTech (Shanghai) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 10, 2024, 111 days after receiving the submission on September 21, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K232955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2023 |
| Decision Date | January 10, 2024 |
| Days to Decision | 111 days |
| Submission Type | Special |
| 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 |