| Device Type ID | 3917 |
| Device Name | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Regulation Description | Uterotubal Carbon Dioxide Insufflator 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 | 884.1300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HES |
| 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 | 3917 |
| Device | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Product Code | HES |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Uterotubal Carbon Dioxide Insufflator And Accessories. |
| CFR Regulation Number | 884.1300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION 2200 INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Deflation Problem | 36 |
Device Operates Differently Than Expected | 17 |
Balloon | 9 |
Difficult To Remove | 2 |
Burst Container Or Vessel | 1 |
Inflation Problem | 1 |
Wire(s), Breakage Of | 1 |
| Total Device Problems | 67 |