Urolab Janus

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K904386 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Life-Tech Intl., Inc. →

• What is the Urolab Janus used for?

  The Urolab Janus is a Cystometric Gas (Carbon-Dioxide) on Hydraulic Device designed specifically for urodynamic testing. It measures bladder function by inflating the bladder with carbon dioxide gas while monitoring pressure responses. This helps clinicians diagnose and evaluate bladder dynamics and lower urinary tract function, making it essential for urology and gastroenterology assessments.

• Is the Urolab Janus reusable or single-use?

  The Urolab Janus is supplied as a reusable medical instrument. It is intended for use in clinical, research, and teaching environments, meaning it can be cleaned, calibrated, and maintained for repeated use. Proper maintenance is required to ensure accurate and reliable performance over time.

• How is the Urolab Janus powered and operated?

  The device operates using hydraulic pressure to inflate the bladder with carbon dioxide gas. This method allows for precise control of bladder pressure during testing, enabling accurate measurement of bladder function. Regular calibration is necessary to maintain the device’s performance and ensure reliable diagnostic results.

• What regulatory approval does the Urolab Janus have?

  The Urolab Janus is authorized for use in the United States under FDA 510(k) clearance with the reference number K904386. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and adheres to regulatory standards outlined in 21 CFR 876.1620.

• Does the Urolab Janus require any special storage or maintenance?

  While specific sterility or MRI safety information is not provided, the Urolab Janus is a reusable device that requires proper calibration and maintenance to ensure accurate and reliable performance. Follow manufacturer guidelines for cleaning, storage, and periodic servicing to extend the device’s lifespan and maintain its diagnostic integrity.