EZL — Catheter, Retention Type, Balloon Class II
FDA product code EZL covers "Catheter, Retention Type, Balloon", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |