Aerin Medical, Inc.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0808-2025 | Class II | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. | November 12, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242630 | Aerin Console | December 10, 2024 |
| K240253 | Reach Needle | March 21, 2024 |
| K221907 | RhinAer® Stylus (FG1393) | July 29, 2022 |
| K200300 | VivAer Stylus | April 13, 2020 |
| K192471 | RHIN1 Stylus | December 20, 2019 |
| K172529 | Vivaer ARC Stylus | December 5, 2017 |
| K162810 | InSeca ARC Stylus, Aerin Console | January 11, 2017 |
| K161994 | Aerin Medical Stylus | September 22, 2016 |
| K150637 | Aerin Medical Wand Model FG011 | November 19, 2015 |