Prosthesis, Urethral Sphincter
The Urethral Sphincter Prosthesis (product code FAG) is an implantable device designed to replace or augment the function of the urethral sphincter in order to restore urinary continence. It is an FDA Class 3 device (highest risk), requiring Premarket Approval (PMA). No regulation number or medical specialty designation has been formally assigned. This device is designated as an implant and is reviewed by the Gastroenterology and Urology panel.
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Basic Information
- Product Code
- FAG
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- GU
- Submission Type
- 2
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.