Total clearances
3
2020-04-29 → 2023-10-19
Name variants in FDA filings: Irras USA / Irras USA, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JXG |
Shunt, Central Nervous System And Components |
Class II |
Neurology |
3 |
2023-10-19 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-10-19 |
K231664 |
IRRAflow Active Fluid Exchange System (AFES) |
JXG |
Class II |
Neurology |
| 2022-12-08 |
K222471 |
IRRAflow Active Fluid Exchange System (AFES) |
JXG |
Class II |
Neurology |
| 2020-04-29 |
K200807 |
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit |
JXG |
Class II |
Neurology |