K112181 is an FDA 510(k) clearance for the HYDROCOIL(R) EMBOLIC SYSTEM (HES). This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on December 1, 2011, 126 days after receiving the submission on July 28, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K112181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2011 |
| Decision Date | December 01, 2011 |
| Days to Decision | 126 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 |