510(k) K212077
- Device
- Teleflex Rusch SoftSimplastic Foley Catheters
- Applicant
- Teleflexmedical, Inc.
- 510(k) number
- K212077
- Product code
- EZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-27
- Date received
- 2021-07-02
- Regulation
- 876.5130
- Classification name
- Catheter, Retention Type, Balloon
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kelley Breheim
- Address
- 3015 Carrington Mill Blvd. Morrisville NC US 27560 27560
FDA Registration Numbers
- 1423662
- 1825146
- 3014637079
- 3022516937
- 1061124
- 3003903031
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Source Documents
Other 510(k) Records For Product Code EZL
| 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 |
| 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 |