Etude, Urodynamic Investigation System

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K901494 ↗

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 Dantec Medical, Inc. →

• What is the ETUDE urodynamic investigation system used for?

  The ETUDE system measures volume and pressure in the urinary bladder when filled via catheter with carbon dioxide or water. It may also record electrical activity of muscles associated with urination, supporting urodynamic assessment in clinical settings.

• Is the ETUDE system sterile or non-sterile, and is it intended for single use or reuse?

  The ETUDE system is supplied as a non-sterile, reusable device. It is intended for multiple uses in clinical environments such as urology or gastroenterology departments, provided it is cleaned and maintained according to manufacturer guidelines.

• What components may be included in the ETUDE urodynamic investigation system?

  The system may include transducers, electronic signal conditioning, and related components necessary for controlling the supply of carbon dioxide or water and recording physiological data during urodynamic assessment.

• How should the ETUDE system be stored and handled?

  Storage and handling of the ETUDE system should follow the manufacturer’s guidelines to ensure proper function and longevity, particularly given its reusable nature and non-sterile supply state.

• What regulatory pathway was used for the ETUDE urodynamic investigation system?

  The ETUDE system was cleared through the FDA 510(k) process under submission K901494, classified as a Class II medical device with product code FAP, and determined to be substantially equivalent to a legally marketed predicate device.