| Device Type ID | 1789 |
| Device Name | Device, Cystometric, Hydraulic |
| Regulation Description | Urodynamics Measurement System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.1620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FEN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1789 |
| Device | Device, Cystometric, Hydraulic |
| Product Code | FEN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urodynamics Measurement System. |
| CFR Regulation Number | 876.1620 [🔎] |
| Device Problems | |
|---|---|
Deflation Problem | 7 |
Leak / Splash | 6 |
No Flow | 5 |
Obstruction Of Flow | 3 |
Defective Component | 3 |
Infusion Or Flow Problem | 3 |
Partial Blockage | 3 |
Blocked Connection | 3 |
Calibration Problem | 3 |
Break | 2 |
Disconnection | 2 |
Crack | 1 |
No Device Output | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Detachment Of Device Or Device Component | 1 |
Sticking | 1 |
Inflation Problem | 1 |
Device Operates Differently Than Expected | 1 |
Display Difficult To Read | 1 |
Difficult To Open Or Close | 1 |
Loss Of Or Failure To Bond | 1 |
Device Difficult To Program Or Calibrate | 1 |
Connection Problem | 1 |
| Total Device Problems | 54 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConvaTec, Inc | II | Aug-10-2018 |