EZL — Catheter, Retention Type, Balloon Class II
FDA Device Classification
Classification Details
- Product Code
- EZL
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252537 | teleflex medical sdn. bhd | Rusch SoftSimplastic Foley Catheters | January 20, 2026 |
| K243011 | guangdong ecan medical co | Silicone Urethral Catheter (Silicone Urethral Catheter) | June 16, 2025 |
| K241424 | innocare urologics | InnoCare Specialty Foley Catheter | September 18, 2024 |
| K232469 | teleflexmedical | Rüsch Latex Gold Foley Catheter | August 1, 2024 |
| K240057 | sentinel medical technologies | TraumaGuard Intra-abdominal Pressure Sensing System | April 17, 2024 |
| K233411 | coloplast | Folysil Silicone Catheter | April 15, 2024 |
| K233013 | silq technologies corporation | 2-Way 100% Silicone Cleartract Catheter | January 23, 2024 |
| K212077 | teleflexmedical | Teleflex Rusch SoftSimplastic Foley Catheters | July 27, 2023 |
| K231101 | flume catheter company | Flume Catheter | June 29, 2023 |
| K221020 | potrero medical | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accu | January 13, 2023 |
| K222118 | silq technologies | 2-Way 100% Silicone Cleartract Catheter | December 1, 2022 |
| K221625 | silq technologies corporation | 2-Way 100% Silicone ClearTract Catheter | July 1, 2022 |
| K212151 | flume catheter company | FLUME catheter | November 3, 2021 |
| K202134 | well lead medical co | Well Lead All Silicone Foley Catheter with Temperature Sensor | April 8, 2021 |
| K201776 | apollon co | Foley Balloon Catheter for Urology | December 30, 2020 |
| K202698 | hangzhou primecare medical co | Prefilled Syringe | December 15, 2020 |
| K192034 | pathway | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley | April 21, 2020 |
| K200556 | h r pharmaceuticals | AquaFlate Pre-Filled Sterile Water Syringe 10mL | March 31, 2020 |
| K182463 | biosensors international pte | Silicone Foley Catheter | November 6, 2019 |
| K190060 | urethrotech | Urethrotech UCD | October 4, 2019 |