The following data is part of a premarket notification filed by Aerin Medical Inc. with the FDA for Rhin1 Stylus.
| Device ID | K192471 |
| 510k Number | K192471 |
| Device Name: | RHIN1 Stylus |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aerin Medical Inc. 232 E Caribbean Dr. Sunnyvale, CA 94089 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull Aerin Medical Inc. 232 E Caribbean Dr. Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-10 |
| Decision Date | 2019-12-20 |