Device Type ID | 3971 |
Device Name | Sound, 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) Exempt |
CFR Regulation Number | 884.4530 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HHM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3971 |
Device | Sound, Uterine |
Product Code | HHM |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
CFR Regulation Number | 884.4530 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Device Handling Problem | 2 |
Insufficient Information | 1 |
Total Device Problems | 7 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Hologic, Inc | II | Nov-22-2016 |