Bard Uroforce Balloon Dilation Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993840 FDA 510(k)
- FDA Product Code
- EZN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5470 FDA 510(k)
- Regulation Number
- 876.5470 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bard Uroforce Balloon Dilation Catheter is a ureteroscopic balloon dilator designed for urological procedures. It is a 6 French dual lumen catheter with a Nydex multilayer balloon mounted on its distal end, intended for precise dilation within the ureter to aid in access and stone management procedures.
This device is supplied individually and is specifically designed for ureteroscopic applications. It is not made with natural rubber latex. The device has received FDA 510(k) clearance with the product code EZN and is classified as a class II medical device for gastroenterology and urology specialties.
Frequently asked questions
What is the Bard Uroforce Balloon Dilation Catheter used for?
The Bard Uroforce Balloon Dilation Catheter is a ureteroscopic balloon dilator designed for urological procedures. It is intended for precise dilation within the ureter to aid in access and stone management procedures.
How is the Bard Uroforce Balloon Dilation Catheter supplied?
The device is supplied individually and is specifically designed for ureteroscopic applications. It is not made with natural rubber latex, making it suitable for patients with latex allergies.
What are the specifications of the Bard Uroforce Balloon Dilation Catheter?
The Bard Uroforce Balloon Dilation Catheter is a 6 French dual lumen catheter with a Nydex multilayer balloon mounted on its distal end. It has received FDA 510(k) clearance with the product code EZN and is classified as a class II medical device for gastroenterology and urology specialties.
What is the regulatory status of the Bard Uroforce Balloon Dilation Catheter?
The Bard Uroforce Balloon Dilation Catheter has received FDA 510(k) clearance with the product code EZN. It is classified as a class II medical device for gastroenterology and urology specialties, indicating it meets specific safety and effectiveness requirements.
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. Sources consulted: Dilation Catheters, Ureteroscopic Balloon, UroForce - BD, Uroforce™ Balloon Dilation Catheter - BD, UroForce Balloon Dilation Catheters - Medline, C.R. Bard 888504 - Uroforce Ureteroscopic Balloon Dilation Catheter ..., CR Bard UroForce Balloon Dilation Catheters - CATHETER, UROFORCET ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993840 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K993840 24 fields · synced Sep 24, 2026