All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton Catheter
FDA 510(k) K980919 · Fortune Medical Instrument Corp.
510(k) numberK980919
Submission
- Device name
- All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton Catheter
- Applicant
- Fortune Medical Instrument Corp.
Irvine, CA, US - Received
- March 11, 1998
- Decision date
- March 31, 1998
- 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
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K022112 | Fortune All Silicone Stomach (Gastric) Tubes, Model 2020KNT · Traditional | 04/03/2003SE |
| K021193 | Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional | 02/12/2003SE |
| K021142 | All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865EZL · Traditional | 10/01/2002SE |
| K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional | 03/04/2002SE |
| K980917 | All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV ReservoirGCA · Traditional | 05/27/1998SE |
Questions and answers
When was All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton Catheter cleared by the FDA?
All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton Catheter (K980919) received a 510(k) decision of Substantially Equivalent on March 31, 1998, 20 days after the submission was received.
What is the product code of K980919?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.