Product code EZL
- Device name
- Catheter, Retention Type, Balloon
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026-01-20 |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | 2024-09-18 |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024-08-01 |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024-04-17 |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024-04-15 |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024-01-23 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023-07-27 |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | 2023-06-29 |
| 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. | 2023-01-13 |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022-12-01 |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022-07-01 |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | 2021-11-03 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2021-04-08 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 |
| 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 | 2020-04-21 |
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | H R Pharmaceuticals, Inc. | 2020-03-31 |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | 2019-11-06 |
| K190060 | Urethrotech UCD | Urethrotech | 2019-10-04 |
| K182635 | Signal Catheter | Safe Medical Design | 2019-01-10 |
| K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018-09-21 |
| K180781 | Bard Vertus Foley Catheter | C.R. Bard, Inc. | 2018-09-19 |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Amsino International, Inc. | 2018-09-04 |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated | 2018-08-23 |
| K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | 2018-08-06 |
| K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 |
| K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 |
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | Poiesis Medical, LLC | 2018-03-29 |
| K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | 2018-02-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08886483507494 | Silicone Foley Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-04 |
| 08886483507487 | Silicone Foley Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-04 |
| 08886483507470 | Silicone Foley Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-04 |
| 10080196030569 | Medline | MEDLINE INDUSTRIES, INC. | 2022-03-29 |
| 08800109201559 | 2Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201566 | 2Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201573 | 2Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201580 | 3Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201597 | 3Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201603 | 3Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201610 | 3Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201627 | 3Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201634 | 3Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-11 |
| 08800109201542 | 2Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-10 |
| 08800109201535 | 2Way Foley Balloon Catheter | AP MDS Co., Ltd. | 2022-02-10 |
| 10080196030545 | Medline | MEDLINE INDUSTRIES, INC. | 2022-01-27 |
| 10080196029198 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196029532 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196030286 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196030323 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196030347 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196030361 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196030385 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196170982 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196182138 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196182145 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196182152 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| H29780010634140 | 8001 Series Foley Catheter Temperature Probe | MEASUREMENT SPECIALTIES, INC. | 2016-07-01 |
| H29744680 | MEAS 4400 Series Temperature Probe | MEASUREMENT SPECIALTIES, INC. | 2016-07-01 |
| H29744640 | MEAS 4400 Series Temperature Probe | MEASUREMENT SPECIALTIES, INC. | 2016-07-01 |