FBX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sound, Urethral, Metal Or Plastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5520
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 1 · 1997: 1 · 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CANDELA URETHRAL/BLADDER SOUND (K950633) | Candela Laser Corp. | 1995-03-06 |
Track FBX automatically
Every clearance here is in the API, with alerts when new ones post.