K210638 is an FDA 510(k) clearance for the i-ED COIL System. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Kaneka Medical America, LLC (New York, US). The FDA issued a Cleared decision on March 26, 2021, 23 days after receiving the submission on March 3, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K210638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2021 |
| Decision Date | March 26, 2021 |
| Days to Decision | 23 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 |