| Device Type ID | 3984 |
| Device Name | Insufflator, Hysteroscopic |
| Regulation Description | Hysteroscopic Insufflator. |
| 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 | 884.1700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HIG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3984 |
| Device | Insufflator, Hysteroscopic |
| Product Code | HIG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hysteroscopic Insufflator. |
| CFR Regulation Number | 884.1700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERMEDX LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERMEDX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W.O.M. WORLD OF MEDICINE AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 3 |
Detachment Of Device Or Device Component | 3 |
Excess Flow Or Over-Infusion | 2 |
Inaccurate Dispensing | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Output Below Specifications | 1 |
Leak / Splash | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Volume Accuracy Problem | 1 |
Mechanics Altered | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Thermedx LLC | II | Apr-20-2015 |