3T/SEWOON Temperature Sensing Foley Catheters
FDA 510(k) K022287 · 3t Medical Systems, LLC
510(k) numberK022287
Submission
- Device name
- 3T/SEWOON Temperature Sensing Foley Catheters
- Applicant
- 3t Medical Systems, LLC
Conifer, CO, US - Received
- July 15, 2002
- Decision date
- September 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| 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 |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072697 | 3T Blood Collection Cardiotomy Reservoirs and AccessoriesDTN · Traditional | 12/20/2007SE |
| K020768 | 3T Vessel CannulasDWF · Traditional | 08/23/2002SE |
| K020365 | 3TM Myocardial Needle-Temperature ProbeKRI · Traditional | 05/03/2002SE |
| K001245 | 3T L. V. Control ValveMJJ · Traditional | 08/15/2001SE |
Questions and answers
When was 3T/SEWOON Temperature Sensing Foley Catheters cleared by the FDA?
3T/SEWOON Temperature Sensing Foley Catheters (K022287) received a 510(k) decision of Substantially Equivalent on September 23, 2002, 70 days after the submission was received.
What is the product code of K022287?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.