K231664 is an FDA 510(k) clearance for the IRRAflow Active Fluid Exchange System (AFES). This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Irras USA, Inc. (San Diego, US). The FDA issued a Cleared decision on October 19, 2023, 134 days after receiving the submission on June 7, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K231664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2023 |
| Decision Date | October 19, 2023 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXG - Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |