Definition: The Device Is Intended To Empty Urine From The Bladder Under Patient Control.
| Device Type ID | 2099 |
| Device Name | Urethral Insert With Pump For Bladder Drainage |
| Physical State | A Catheter-like Device With Internal Pump Mechanism That Is Placed In The Urethra. |
| Technical Method | Under Patient Control, The Internal Pump Inside The Urethral Insert Draws Urine Out Of The Bladder When Voiding Is Desired, And Blocks Urine Flow When Continence Is Desired. |
| Target Area | The Device Is Placed In The Urethra. |
| Regulation Description | Urethral Insert With Pump For Bladder Drainage. |
| 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) |
| CFR Regulation Number | 876.5140 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2099 |
| Device | Urethral Insert With Pump For Bladder Drainage |
| Product Code | PIH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urethral Insert With Pump For Bladder Drainage. |
| CFR Regulation Number | 876.5140 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
VESIFLO, INC. | ||
GRANTED | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
Catheter | 1 |
| Total Device Problems | 2 |