| Device Type ID | 3979 |
| Device Name | Pessary, Vaginal |
| Regulation Description | Vaginal Pessary. |
| 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 | 884.3575 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HHW |
| 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 | 3979 |
| Device | Pessary, Vaginal |
| Product Code | HHW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vaginal Pessary. |
| CFR Regulation Number | 884.3575 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PANPAC MEDICAL CORPO | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PANPAC MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PROCTER & GAMBLE CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Use Of Device Problem | 1 |
Device Operates Differently Than Expected | 1 |
Fluid Leak | 1 |
Insufficient Information | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | May-09-2017 |
| 2 | CooperSurgical, Inc. | III | Nov-10-2015 |
| 3 | CooperSurgical, Inc. | II | Mar-03-2015 |
| 4 | CooperSurgical, Inc. | III | Nov-13-2014 |