| Device Type ID | 3919 |
| Device Name | Culdoscope (and Accessories) |
| Regulation Description | Culdoscope 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 | 884.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HEW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3919 |
| Device | Culdoscope (and Accessories) |
| Product Code | HEW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Culdoscope And Accessories. |
| CFR Regulation Number | 884.1640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED MEDICAL RESOURCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
APPLIED MEDICAL RESOURCES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOPERSURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Overheating Of Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Oct-11-2018 |