The following data is part of a premarket notification filed by Innoblative Designs, Inc. with the FDA for Sira Rfa Electrosurgical Device.
| Device ID | K181071 |
| 510k Number | K181071 |
| Device Name: | SIRA RFA Electrosurgical Device |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Innoblative Designs, Inc. 4660 Ravenswood Avenue Chicago, IL 60640 |
| Contact | Tyler Wanke |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-23 |
| Decision Date | 2019-01-16 |
| Summary: | summary |