Urolab Spectrum

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K931179 ↗

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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• What is the UROLAB SPECTRUM used for?

  The UROLAB SPECTRUM is a cystometric gas (carbon-dioxide) on hydraulic device designed for diagnostic purposes in gastroenterology and urology medical settings.

• Is the UROLAB SPECTRUM a single-use device?

  The device is not specified as single-use or reusable in the provided information.

• What is the regulatory classification of the UROLAB SPECTRUM?

  The UROLAB SPECTRUM is classified as a Class II medical device and received FDA 510(k) clearance with the K number K931179.

• What are the specialties associated with the UROLAB SPECTRUM?

  The device is associated with gastroenterology and urology specialties as indicated by the advisory committee description.