Browne Uroscan Urodynamic
510(k) K880504
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880504 | Date17 Jun 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Mct Medical Browne Uroscan Urodynamic
- 510(k) Number
- FDA Product Code
- EXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1800
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Browne Uroscan Urodynamic is a uroflowmeter, a diagnostic device used to measure urinary flow rate and bladder function. It evaluates voiding dynamics by recording the rate at which urine exits the bladder, helping assess conditions such as urinary retention, obstruction, or dysfunction. The device provides quantitative data to support clinical assessments in urology and related specialties.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings, including hospitals and urology practices. It has received FDA 510(k) clearance under classification EXY (Urological Devices) and is regulated under 21 CFR 876.1800. No third-party certification or additional sterility requirements are noted in the regulatory records. The device is listed under the Gastroenterology, Urology advisory committee and has been assigned the K-number K880504.
Other devices from Mct Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Browne Uroscan Urodynamic used for?
The Browne Uroscan Urodynamic is a uroflowmeter designed to evaluate urinary flow dynamics by recording how quickly urine exits the bladder. This quantitative data helps clinicians diagnose and assess conditions such as urinary retention, obstruction, or dysfunction in urology patients. It provides objective measurements to support clinical decision-making.
Is the Browne Uroscan Urodynamic reusable or single-use?
The Browne Uroscan Urodynamic is supplied as a reusable medical instrument. It is intended for use in clinical settings like hospitals and urology practices, where it can be cleaned, disinfected, and reused according to established protocols. Reusability ensures cost-effectiveness and reduces waste, though proper maintenance and sterilization procedures must be followed.
Does the device require third-party sterility certification?
No, the regulatory records for the Browne Uroscan Urodynamic do not specify any additional third-party sterility requirements beyond standard clinical cleaning and disinfection protocols. The device is regulated under 21 CFR 876.1800 and is cleared for reusable use in clinical environments.
What regulatory approval does the Browne Uroscan Urodynamic hold?
The Browne Uroscan Urodynamic has received FDA 510(k) clearance under classification EXY (Urological Devices). This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, allowing it to enter the market legally in the U.S. The device is also listed under the Gastroenterology, Urology advisory committee.
How is the device supplied and what are its key specifications?
The Browne Uroscan Urodynamic is supplied as a reusable clinical instrument, intended for use in hospitals and urology practices. It is designed to measure urinary flow rates and assess bladder function, providing quantitative data for diagnostic purposes. The device falls under the classification of a Class II medical device (device class=2) and is regulated under the product code EXY for urological devices.