The following data is part of a premarket notification filed by Aerin Medical, Inc. with the FDA for Inseca Arc Stylus, Aerin Console.
| Device ID | K162810 |
| 510k Number | K162810 |
| Device Name: | InSeca ARC Stylus, Aerin Console |
| 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 | 2016-10-06 |
| Decision Date | 2017-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08886479300214 | K162810 | 000 |
| 08886479300122 | K162810 | 000 |
| 08886479300207 | K162810 | 000 |
| 08886479300221 | K162810 | 000 |
| 08886479300023 | K162810 | 000 |
| 08886479300030 | K162810 | 000 |
| 08886479300047 | K162810 | 000 |
| 08886479300115 | K162810 | 000 |
| 08886479300139 | K162810 | 000 |
| 08886479300108 | K162810 | 000 |