Puller Option for Etude

No FDA recalls on record, checked 6 Oct 2026.

Full name

Puller Option for Etude(Tm)

510(k) Number

K914891 ↗

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 Puller Option for Etude used for?

  The Puller Option for Etude is a cystometric gas (carbon-dioxide) on hydraulic device designed to assist in urodynamic testing procedures, specifically in gastroenterology and urology applications where precise pressure measurements are needed during diagnostic evaluations.

• Is the Puller Option for Etude reusable or single-use?

  The Puller Option for Etude is supplied as a reusable accessory, meaning it can be cleaned and used multiple times following the manufacturer's reprocessing instructions, which helps reduce long-term costs for clinical facilities performing frequent urodynamic studies.

• What regulatory clearance does the Puller Option for Etude have?

  The Puller Option for Etude is regulated under FDA 510(k) clearance K914891, which was granted as a Traditional 510(k) submission on January 7, 1992, after being found substantially equivalent to a legally marketed predicate device.