The following data is part of a premarket notification filed by Aerin Medical, Inc. with the FDA for Aerin Medical Wand Model Fg011.
| Device ID | K150637 |
| 510k Number | K150637 |
| Device Name: | Aerin Medical Wand Model FG011 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aerin Medical, Inc. 690 W. Fremont Avenue Unit 3 Sunnyvale, CA 94087 |
| Contact | Scott Wolf |
| Correspondent | Scott Wolf 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-11-19 |
| Summary: | summary |