Urethral Insert With Pump For Bladder Drainage
The Urethral Insert with Pump for Bladder Drainage is a urology device intended to empty urine from the bladder under patient control, providing an alternative to intermittent catheterization for patients with urinary retention or voiding dysfunction. It is an FDA Class 2 device regulated under 21 CFR 876.5140, requiring 510(k) clearance, within the Gastroenterology and Urology (GU) medical specialty. The product code is PIH, and it is flagged as an implant due to its urethral insertion. This device is not life-sustaining.
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Basic Information
- Product Code
- PIH
- Device Class
- FDA class 2
- Regulation Number
- 876.5140
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to empty urine from the bladder under patient control.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN130044 | INFLOW INTRAURETHRAL VALVE-PUMP | Oct 14, 2014 | Unknown | Vesiflo, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.