FAG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Urethral Sphincter
- Device class
- Class III (high risk)
- Medical specialty
- Unknown
- Flags
- Implant
- Adverse events (MAUDE)
- 1994: 4 · 1995: 1 · 1996: 8 · 2011: 18 · 2012: 10 · 2013: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| AMS SPHINCTER 800 URINARY PROSTHESIS (K912934) | American Medical Systems, Inc. | 1992-03-18 | + Add |
| THE ARTIFICIAL URINARY SPHINCTER (K821627) | American Medical Systems, Inc. | 1982-08-10 | + Add |
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Every clearance here is in the API, with alerts when new ones post.