Device Type ID | 4022 |
Device Name | Catheters, Salpingography |
Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
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 | 884.4530 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MOV |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4022 |
Device | Catheters, Salpingography |
Product Code | MOV |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
CFR Regulation Number | 884.4530 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Material Separation | 3 |
Device Operates Differently Than Expected | 1 |
Total Device Problems | 4 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Cook Inc. | II | Aug-22-2016 |