Data / Medical devices / United States / Aerin Medical Inc.
Aerin Medical Inc.: FDA-registered device maker in Mountain View, CA, United States, 8 510(k) clearances
Aerin Medical Inc. is registered with the FDA (registration 3011625895) in Mountain View, CA, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 18, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011625895
- Address
- 2565 Leghorn St., Mountain View, CA, United States, 94043
- Owner or operator
- Aerin Medical Inc. (10050618)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- November 16, 2017
- Registered through
- 2026
- Brand names listed
- Aerin Console, InSeca ARC Stylus, Reach Needle, RhinAer Stylus, RhinAer+ Stylus, RhinAer Stylus, VivAer® Stylus, Vivaer ARC Stylus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2026 | K260522 | RhinAer+ Stylus | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| December 10, 2024 | K242630 | Aerin Console | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| March 21, 2024 | K240253 | Reach Needle | BSP | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| July 29, 2022 | K221907 | RhinAer® Stylus (FG1393) | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| April 13, 2020 | K200300 | VivAer Stylus | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| December 20, 2019 | K192471 | RHIN1 Stylus | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| December 5, 2017 | K172529 | Vivaer ARC Stylus | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
| January 11, 2017 | K162810 | InSeca ARC Stylus, Aerin Console | GEI | Substantially Equivalent | Aerin Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 12, 2024 | 95832 | Class II | Ongoing | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. | Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
Updated May 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.