The following data is part of a premarket notification filed by Obsidio, Inc. with the FDA for Gem.
| Device ID | K213385 |
| 510k Number | K213385 |
| Device Name: | GEM |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Obsidio, Inc. 1520 Main Street, Unit 4-C Columbia, SC 29201 |
| Contact | Ehsan Jabbarzadeh |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2320 Philadelphia, PA 19103 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-13 |
| Decision Date | 2022-07-01 |