The following data is part of a premarket notification filed by Aerin Medical, Inc. with the FDA for Aerin Medical Stylus.
| Device ID | K161994 |
| 510k Number | K161994 |
| Device Name: | Aerin Medical Stylus |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aerin Medical, Inc. 690 W. Fremont Avenue, Unit 3 Sunnyvale, CA 94087 |
| Contact | Scott Wolf |
| Correspondent | Shannon Scott Aerin Medical, Inc. 690 W. Fremont Avenue, Unit 3 Sunnyvale, CA 94087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-19 |
| Decision Date | 2016-09-22 |
| Summary: | summary |