K240871 is an FDA 510(k) clearance for the Synxess Neurovascular Guidewire. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Enlight Medical Technologies (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 18, 2024, 234 days after receiving the submission on March 29, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K240871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2024 |
| Decision Date | November 18, 2024 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MOF - Guide, Wire, Catheter, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |