Coaxial Balloon Urethral Dilator
by American Edwards Laboratories 510(k)
Active
510(k) K833690
Overview
The Coaxial Balloon Urethral Dilator is a Replacer, Urethral device, classified under FDA Class III. It is designed to facilitate urethral dilation by expanding the urethral lumen using an inflatable balloon mechanism, aiding in procedures such as urethral stricture management or catheter placement.
This device is supplied as a single-use, non-sterile instrument and is intended for use in clinical settings where sterile conditions can be achieved. It is regulated under FDA 510(k) clearance (K833690) with a product code of FAA, and its design was determined to be substantially equivalent to a legally marketed predicate. No MRI safety information or additional size specifications are provided in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833690 | Date29 Nov 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FAA
- Device Class
- Class III
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent
Other devices from American Edwards Laboratories
Questions
What is the primary purpose of the Coaxial Balloon Urethral Dilator in clinical procedures?
The Coaxial Balloon Urethral Dilator is designed to help expand the urethral lumen during procedures like urethral stricture management or catheter placement. Its inflatable balloon mechanism allows controlled dilation, making it useful when precise urethral widening is needed.
Is this device intended for repeated use, or is it meant to be used only once?
This device is explicitly labeled as single-use only. While it is non-sterile as shipped, it is intended for use in clinical settings where sterile conditions can be achieved before deployment, ensuring patient safety.
How is the Coaxial Balloon Urethral Dilator regulated in the U.S., and what does that mean for its use?
The device holds FDA 510(k) clearance (K833690) under product code FAA, classified as a Class III Replacer device. This means its safety and effectiveness were compared to a legally marketed predicate device, confirming it meets regulatory standards for urethral dilation procedures.
What storage conditions should be considered before using this device?
Since the device is non-sterile as supplied, it must be sterilized in a clinical setting before use. No specific storage instructions are provided beyond ensuring it remains in a clean, protected environment until sterilization and deployment.
Are there different sizes or models available for this device?
The regulatory data does not specify any additional size variations or model distinctions for the Coaxial Balloon Urethral Dilator. Clinicians should confirm compatibility with patient anatomy and procedural needs based on standard urethral dilation requirements.