EZO
5 FDA 510(k) clearances · Product code
102 daysmedian time to decision
664 days90th percentile
5clearances measured
FDA profile
- Official device name
- Urethrotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4770
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2002: 4 · 2003: 5 · 2007: 3 · 2009: 3 · 2010: 4 · 2012: 5
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 |
|---|---|---|
| URETHROTOME 8667.XXX AND 8670.XXX (K000905) | Richard Wolf Medical Instruments Corp. | 2000-05-12 |
| OES UROLOGY (K950719) | Olympus America, Inc. | 1996-12-11 |
| KARL STORZ KNIVES, CURETTES (K945686) | KARL STORZ Endoscopy-America, Inc. | 1995-02-13 |
| KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (K934730) | KARL STORZ Endoscopy-America, Inc. | 1994-01-11 |
| FLEXIBLE AND RIGID URETEROTOME SYSTEM (K904939) | Olympus Corp. | 1992-01-07 |
Track EZO automatically
Every clearance here is in the API, with alerts when new ones post.