Rüsch Latex Gold Foley Catheter
FDA 510(k) K232469 · Teleflexmedical, Inc.
510(k) numberK232469
Submission
- Device name
- Rüsch Latex Gold Foley Catheter
- Applicant
- Teleflexmedical, Inc.
Morrisville, NC, US - Received
- August 15, 2023
- Decision date
- August 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZL – Catheter, Retention Type, Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
| K231101 | Flume CatheterEZL · Special | Flume Catheter Company, Ltd. | 06/29/2023SE |
More from Flume Catheter Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | 07/27/2023SE |
| K192324 | Sheridan Spiral-Flex Endotracheal TubesBTR · Traditional | 12/06/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | 07/01/2019SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | 05/24/2019SE |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…GBM · Traditional | 05/08/2019SESK |
| K181852 | Percuvance Percutaneous Surgical SystemGEI · Traditional | 10/12/2018SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | 08/02/2018SE |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCW · Traditional | 02/12/2018SE |
| K161770 | Rusch Silicone Foley CatheterEZL · Traditional | 05/05/2017SE |
| K162522 | UltraCath Continuous Nerve block CatheterBSO · Traditional | 03/17/2017SE |
Questions and answers
When was Rüsch Latex Gold Foley Catheter cleared by the FDA?
Rüsch Latex Gold Foley Catheter (K232469) received a 510(k) decision of Substantially Equivalent on August 1, 2024, 352 days after the submission was received.
What is the product code of K232469?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.