PIH — Urethral Insert With Pump For Bladder Drainage Class II
FDA product code PIH covers "Urethral Insert With Pump For Bladder Drainage", a Class II medical device regulated under 21 CFR 876.5140. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PIH
- Device Class
- Class II
- Regulation Number
- 876.5140
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
The device is intended to empty urine from the bladder under patient control.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN130044 | vesiflo | INFLOW INTRAURETHRAL VALVE-PUMP | October 14, 2014 |