EZL · Catheter, Retention Type, Balloon
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | EZL |
|---|---|
| Device Name | Catheter, Retention Type, Balloon |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Classification Rationale
(1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 128)
Showing 20 most recent of 128 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | Jan 20, 2026 | SESE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | Jun 16, 2025 | SESE |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | Sep 18, 2024 | SESE |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | Aug 1, 2024 | SESE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | Apr 17, 2024 | SESE |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | Apr 15, 2024 | SESE |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | Jan 23, 2024 | SESE |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | Jul 27, 2023 | SESE |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | Jun 29, 2023 | SESE |
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | Potrero Medical, Inc. | Jan 13, 2023 | SESK |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | Dec 1, 2022 | SESE |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | Jul 1, 2022 | SESE |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | Nov 3, 2021 | SESE |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | Apr 8, 2021 | SESE |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | Dec 30, 2020 | SESE |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | Dec 15, 2020 | SESE |
| K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc | Pathway, LLC | Apr 21, 2020 | SESE |
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | H R Pharmaceuticals, Inc. | Mar 31, 2020 | SESE |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | Nov 6, 2019 | SESE |
| K190060 | Urethrotech UCD | Urethrotech | Oct 4, 2019 | SESE |
Top Applicants
- C.R. Bard, Inc. — 10 clearances
- Regulatory & Marketing Services, Inc. — 6 clearances
- Amsino International, Inc. — 5 clearances
- Rusch Intl. — 4 clearances
- Teleflexmedical, Inc. — 4 clearances
