| Device Type ID | 3896 |
| Device Name | Diaphragm, Contraceptive (and Accessories) |
| Regulation Description | Contraceptive Diaphragm And Accessories. |
| 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 | 884.5350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HDW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 3896 |
| Device | Diaphragm, Contraceptive (and Accessories) |
| Product Code | HDW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Contraceptive Diaphragm And Accessories. |
| CFR Regulation Number | 884.5350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KESSEL MEDINTIM GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fitting Problem | 3 |
Malfunction | 2 |
Defective Device | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Mar-04-2016 |
| 2 | CooperSurgical, Inc. | II | Jun-18-2015 |