| Device Type ID | 3870 |
| Device Name | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Regulation Description | Vascular Embolization Device. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NAJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3870 |
| Device | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Product Code | NAJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vascular Embolization Device. |
| CFR Regulation Number | 870.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CELONOVA BIOSCIENCES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 20 |
Therapy Delivered To Incorrect Body Area | 8 |
Migration Or Expulsion Of Device | 3 |
Use Of Device Problem | 1 |
Unsealed Device Packaging | 1 |
Device Packaging Compromised | 1 |
Insufficient Information | 1 |
Missing Value Reason | 1 |
| Total Device Problems | 36 |