All Silicone 2-Way & 3-Way Foly Balloon Catheter And Nelaton Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980919 FDA 510(k)
- FDA Product Code
- EZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Catheter, Retention Type, Balloon, designed for urinary drainage and retention. It features a 2-way or 3-way silicone Foley balloon catheter combined with a Nelaton catheter, providing both drainage and balloon inflation capabilities for secure placement within the urinary tract. The silicone construction ensures biocompatibility and flexibility for patient comfort during use.
The All Silicone 2-Way & 3-Way Foley Balloon Catheter and Nelaton Catheter is intended for single-use in clinical settings such as hospitals and outpatient care. Supplied sterile, it is classified as Class II under FDA regulations and has received FDA 510K clearance, MDD, and MDR authorizations. Available in multiple sizes, it adheres to Gastroenterology and Urology specialty standards and is registered under registration number 8022978 and regulation number 876.5130.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K980919 | Class II | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (2)
- FDA 510(k) K980919 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026