| Device Type ID | 3920 |
| Device Name | Colposcope (and Colpomicroscope) |
| Regulation Description | Colposcope. |
| 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 | 884.1630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HEX |
| 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 | 3920 |
| Device | Colposcope (and Colpomicroscope) |
| Product Code | HEX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Colposcope. |
| CFR Regulation Number | 884.1630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOPER SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOPERSURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYNIUS AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 1 |