Urocomp Remote Control 1804

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

510(k) Number

K822916 ↗

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 primary clinical application for the Urocomp Remote Control 1804?

  This device is designed for use in both urological and gastroenterological applications, functioning as a cystometric gas carbon-dioxide on hydraulic system.

• Under what regulatory framework is this device managed?

  The Urocomp Remote Control 1804 is regulated under FDA 510k clearance K822916, which confirms it was found to be substantially equivalent to existing devices under regulation number 876.1620.

• Who is the manufacturer of the Urocomp Remote Control 1804?

  The device is manufactured by Life-Tech Intl., Inc., based in Houston, Texas.