Device Type ID | 3931 |
Device Name | Prosthesis, Fallopian Tube |
Regulation Description | Fallopian Tube Prosthesis. |
Regulation Medical Specialty | Obstetrics/Gynecology |
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 | 884.3650 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HFJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3931 |
Device | Prosthesis, Fallopian Tube |
Product Code | HFJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Fallopian Tube Prosthesis. |
CFR Regulation Number | 884.3650 [🔎] |
Device Problems | |
---|---|
Migration Or Expulsion Of Device | 1 |
Total Device Problems | 1 |