| Device Type ID | 4025 |
| Device Name | Catheter, Assisted Reproduction |
| Regulation Description | Assisted Reproduction Catheters. |
| 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 | 884.6110 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4025 |
| Device | Catheter, Assisted Reproduction |
| Product Code | MQF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Catheters. |
| CFR Regulation Number | 884.6110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
FERTILIGENT, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KITAZATO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDGYN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDGYN PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORIGIO A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 19 |
Contamination / Decontamination Problem | 7 |
Catheter | 7 |
Device Contaminated During Manufacture Or Shipping | 5 |
Material Separation | 5 |
Break | 3 |
Device Operates Differently Than Expected | 3 |
Difficult To Advance | 2 |
Material Too Rigid Or Stiff | 2 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Bent | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 57 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Mar-26-2018 |