EZC
7 FDA 510(k) clearances · Product code
170 daysmedian time to decision
205 days90th percentile
7clearances measured
FDA profile
- Official device name
- Catheter, Coude
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 1,030 · 2022: 1,365 · 2023: 1,142 · 2024: 957 · 2025: 1,231 · 2026: 560
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 |
|---|---|---|
| Rusch Intermittent Urethral Catheters (K222279) | Teleflex Medical | 2022-08-29 |
| Rusch Intermittent Urethral Catheters (K173596) | Teleflex Medical | 2018-01-29 |
| UNIVERSAL URETHRAL CATHETER (K946282) | Louisville Laboratories, Inc. | 1995-03-31 |
| BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (K913341) | C.R. Bard, Inc. | 1992-01-27 |
| BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF (K910846) | C.R. Bard, Inc. | 1991-08-16 |
| HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS (K910197) | C.R. Bard, Inc. | 1991-08-09 |
| BARD HYDROGEL-COATED FOLEY CATHETERS (K910195) | C.R. Bard, Inc. | 1991-08-09 |
Track EZC automatically
Every clearance here is in the API, with alerts when new ones post.