EZL
- Product code
- EZL
- Device name
- Catheter, Retention Type, Balloon
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 129 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262056 | 2026-08-05 | Teleflex Medical Sdn. Bhd. | Rusch Latex Gold Foley Catheter | |
| K252537 | 2026-01-20 | Teleflex Medical Sdn. Bhd. | Rusch SoftSimplastic Foley Catheters | |
| K243011 | 2025-06-16 | Guangdong Ecan Medical Co., Ltd. | Silicone Urethral Catheter (Silicone Urethral Cathet… | |
| K241424 | 2024-09-18 | Innocare Urologics, LLC | InnoCare Specialty Foley Catheter | |
| K232469 | 2024-08-01 | Teleflexmedical, Inc. | Rüsch Latex Gold Foley Catheter | FDA |
| K240057 | 2024-04-17 | Sentinel Medical Technologies, LLC | TraumaGuard Intra-abdominal Pressure Sensing System | |
| K233411 | 2024-04-15 | Coloplast Corp. | Folysil Silicone Catheter | |
| K233013 | 2024-01-23 | Silq Technologies Corporation | 2-Way 100% Silicone Cleartract Catheter |
Official FDA classification page: EZL
Classification and pathway per current FDA publications. Data from openFDA (CC0).