| Device Type ID | 3981 |
| Device Name | Speculum, Vaginal, Nonmetal |
| 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) Exempt |
| CFR Regulation Number | 884.4530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HIB |
| 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 | 3981 |
| Device | Speculum, Vaginal, Nonmetal |
| Product Code | HIB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IOB MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 9 |
Shipping Damage Or Problem | 8 |
Fracture | 3 |
Physical Property Issue | 1 |
| Total Device Problems | 21 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Jun-22-2015 |
| 2 | Welch Allyn Inc | II | Oct-30-2015 |