| Device Type ID | 3879 |
| Device Name | Tenaculum, Uterine |
| 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) |
| CFR Regulation Number | 884.4530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HDC |
| 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 | 3879 |
| Device | Tenaculum, Uterine |
| Product Code | HDC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Instrumed International, Inc. | II | Dec-16-2014 |