EZB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stylet For Catheter, Gastro-Urology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2021: 69 · 2022: 103 · 2023: 178 · 2024: 133 · 2025: 152 · 2026: 64
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 |
|---|---|---|
| APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (K971498) | Applied Medical Resources | 1997-05-05 |
| CORE AND COIL ASSEMBLY GUIDEWIRE (K970994) | Lake Region Mfg., Inc. | 1997-03-25 |
| GUIDE WIRE (K874164) | Endovations | 1987-12-07 |
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Every clearance here is in the API, with alerts when new ones post.